Trial Outcomes & Findings for Study to Assess PDM608 in Healthy Adult Subjects (NCT NCT05950906)
NCT ID: NCT05950906
Last Updated: 2025-11-18
Results Overview
Adverse events will be analyzed for severity and potential relationship to PDM608 to determine safety and tolerability of PDM608
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
64 participants
Primary outcome timeframe
Part 1: Day 1 through Day 5; Part 2: Day 1 through Day 26
Results posted on
2025-11-18
Participant Flow
Participant enrollment was reported as a combined arm (reporting PDM608 and Placebo subjects) to in sections where there is no major benefit to differentiate between treatment vs placebo. Comments were added to Part 2 MAD SC Placebo Cohort 2 to denote that the two subjects who didn't complete the study were assigned to receive active treatment. For the PK and ADA, analysis was only done on subjects who received PDM608.
Participant milestones
| Measure |
Part 1 SAD SC PDM608 Cohort 1
One time subcutaneous administration of 350 ug of PDM608. 6 subjects received PDM608
|
Part 1 SAD SC Placebo Cohort 1
One time subcutaneous administration of 350 ug of PDM608. 2 subjects received Placebo.
|
Part 1 SAD SC PDM608 Cohort 2
One time subcutaneous administration of 1050 ug of PDM608.
2 subjects received Placebo.
|
Part 1 SAD SC Placebo Cohort 2
One time subcutaneous administration of 1050 ug of PDM608.
2 subjects received Placebo.
|
Part 1 SAD SC PDM608 Cohort 3
One time subcutaneous administration of 3150 ug of PDM608.
6 subjects received PDM608.
|
Part 1 SAD SC Placebo Cohort 3
One time subcutaneous administration of 3150 ug of PDM608.
2 subjects received Placebo.
|
Part 1 SAD SC PDM608 Cohort 4
One time subcutaneous administration of 6300 ug of PDM608.
6 subjects received PDM608.
|
Part 1 SAD SC Placebo Cohort 4
One time subcutaneous administration of 6300 ug of PDM608.
2 subjects received Placebo.
|
Part 1 SAD SC PDM608 Cohort 5
One time subcutaneous administration of 12600 ug of PDM608.
6 subjects received PDM60.
|
Part 1 SAD SC Placebo Cohort 5
One time subcutaneous administration of 12600 ug of PDM608.
2 subjects received Placebo.
|
Part 2 MAD SC PDM608 Cohort 1
Subcutaneous administration of 6300ug of PDM608/Placebo once weekly for 4 weeks.
9 subjects received PDM608
|
Part 2 MAD SC Placebo Cohort 1
Subcutaneous administration of 6300ug of PDM608/Placebo once weekly for 4 weeks.
3 subjects received Placebo
|
Part 2 MAD SC PDM608 Cohort 2
Subcutaneous administration of 12600ug of PDM608/Placebo once weekly for 4 weeks.
9 subjects received PDM608 on week 1. 2 subjects were withdrawn per PI's discretion before receiving all 4 weekly doses of PDM608.
|
Part 2 MAD SC Placebo Cohort 2
Subcutaneous administration of 12600ug of PDM608/Placebo once weekly for 4 weeks.
3 subjects received Placeb
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
2
|
6
|
2
|
6
|
2
|
6
|
2
|
6
|
2
|
9
|
3
|
9
|
3
|
|
Overall Study
COMPLETED
|
6
|
2
|
6
|
2
|
6
|
2
|
6
|
2
|
6
|
2
|
9
|
3
|
7
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
0
|
Reasons for withdrawal
| Measure |
Part 1 SAD SC PDM608 Cohort 1
One time subcutaneous administration of 350 ug of PDM608. 6 subjects received PDM608
|
Part 1 SAD SC Placebo Cohort 1
One time subcutaneous administration of 350 ug of PDM608. 2 subjects received Placebo.
|
Part 1 SAD SC PDM608 Cohort 2
One time subcutaneous administration of 1050 ug of PDM608.
2 subjects received Placebo.
|
Part 1 SAD SC Placebo Cohort 2
One time subcutaneous administration of 1050 ug of PDM608.
2 subjects received Placebo.
|
Part 1 SAD SC PDM608 Cohort 3
One time subcutaneous administration of 3150 ug of PDM608.
6 subjects received PDM608.
|
Part 1 SAD SC Placebo Cohort 3
One time subcutaneous administration of 3150 ug of PDM608.
2 subjects received Placebo.
|
Part 1 SAD SC PDM608 Cohort 4
One time subcutaneous administration of 6300 ug of PDM608.
6 subjects received PDM608.
|
Part 1 SAD SC Placebo Cohort 4
One time subcutaneous administration of 6300 ug of PDM608.
2 subjects received Placebo.
|
Part 1 SAD SC PDM608 Cohort 5
One time subcutaneous administration of 12600 ug of PDM608.
6 subjects received PDM60.
|
Part 1 SAD SC Placebo Cohort 5
One time subcutaneous administration of 12600 ug of PDM608.
2 subjects received Placebo.
|
Part 2 MAD SC PDM608 Cohort 1
Subcutaneous administration of 6300ug of PDM608/Placebo once weekly for 4 weeks.
9 subjects received PDM608
|
Part 2 MAD SC Placebo Cohort 1
Subcutaneous administration of 6300ug of PDM608/Placebo once weekly for 4 weeks.
3 subjects received Placebo
|
Part 2 MAD SC PDM608 Cohort 2
Subcutaneous administration of 12600ug of PDM608/Placebo once weekly for 4 weeks.
9 subjects received PDM608 on week 1. 2 subjects were withdrawn per PI's discretion before receiving all 4 weekly doses of PDM608.
|
Part 2 MAD SC Placebo Cohort 2
Subcutaneous administration of 12600ug of PDM608/Placebo once weekly for 4 weeks.
3 subjects received Placeb
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Physician Decision
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Study to Assess PDM608 in Healthy Adult Subjects
Baseline characteristics by cohort
| Measure |
Part 1 SAD SC PDM608 Cohort 1
n=6 Participants
Single SC administration dose of 350 ug PDM608
|
Part 1 SAD SC PDM608/Placebo Cohort 1
n=2 Participants
Single SC administration dose of 350 ug Placebo
|
Part 1 SAD SC PDM608 Cohort 2
n=6 Participants
Single SC administration dose of 1050 ug PDM608
|
Part 1 SAD SC Placebo Cohort 2
n=2 Participants
Single SC administration dose of 1050 ug Placebo
|
Part 1 SAD SC PDM608Cohort 3
n=6 Participants
Single SC administration dose of 3150 ug PDM608
|
Part 1 SAD SC Placebo Cohort 3
n=2 Participants
Single SC administration dose of 3150 ug Placebo
|
Part 1 SAD SC PDM608 Cohort 4
n=6 Participants
Single SC administration dose of 6300 ug PDM608
|
Part 1 SAD SC Placebo Cohort 4
n=2 Participants
Single SC administration dose of 6300 ug Placebo
|
Part 1 SAD SC PDM608 Cohort 5
n=6 Participants
Single SC administration dose of 12600 ug PDM608
|
Part 1 SAD SC Placebo Cohort 5
n=2 Participants
Single SC administration dose of 12600 ug Placebo
|
Part 2 MAD SC PDM608 Cohort 1
n=9 Participants
Once a week subcutaneous administration of 6300 ug of PDM608 for 4 weeks
|
Part 2 MAD SC Placebo Cohort 1
n=3 Participants
Once a week subcutaneous administration of 6300 ug of Placebo for 4 weeks
|
Part 2 MAD SC PDM608 Cohort 2
n=7 Participants
Once a week subcutaneous administration of 12600 ug of PDM608 for 4 weeks
|
Part 2 MAD SC Placebo Cohort 2
n=3 Participants
Once a week subcutaneous administration of 12600 ug of Placebo for 4 weeks
|
Total
n=62 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=39 Participants
|
0 Participants
n=29 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=185 Participants
|
0 Participants
n=740 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=80 Participants
|
0 Participants
n=94 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=29 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=13 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=39 Participants
|
2 Participants
n=29 Participants
|
6 Participants
n=60 Participants
|
2 Participants
n=185 Participants
|
6 Participants
n=740 Participants
|
2 Participants
n=1 Participants
|
6 Participants
n=80 Participants
|
2 Participants
n=94 Participants
|
6 Participants
n=27 Participants
|
2 Participants
n=29 Participants
|
9 Participants
n=2 Participants
|
3 Participants
n=30 Participants
|
7 Participants
n=3 Participants
|
3 Participants
n=13 Participants
|
62 Participants
n=13 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=39 Participants
|
0 Participants
n=29 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=185 Participants
|
0 Participants
n=740 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=80 Participants
|
0 Participants
n=94 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=29 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=13 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=39 Participants
|
0 Participants
n=29 Participants
|
1 Participants
n=60 Participants
|
1 Participants
n=185 Participants
|
1 Participants
n=740 Participants
|
1 Participants
n=1 Participants
|
2 Participants
n=80 Participants
|
1 Participants
n=94 Participants
|
1 Participants
n=27 Participants
|
0 Participants
n=29 Participants
|
2 Participants
n=2 Participants
|
1 Participants
n=30 Participants
|
1 Participants
n=3 Participants
|
1 Participants
n=13 Participants
|
15 Participants
n=13 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=39 Participants
|
2 Participants
n=29 Participants
|
5 Participants
n=60 Participants
|
1 Participants
n=185 Participants
|
5 Participants
n=740 Participants
|
1 Participants
n=1 Participants
|
4 Participants
n=80 Participants
|
1 Participants
n=94 Participants
|
5 Participants
n=27 Participants
|
2 Participants
n=29 Participants
|
7 Participants
n=2 Participants
|
2 Participants
n=30 Participants
|
6 Participants
n=3 Participants
|
2 Participants
n=13 Participants
|
47 Participants
n=13 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=39 Participants
|
2 Participants
n=29 Participants
|
6 Participants
n=60 Participants
|
2 Participants
n=185 Participants
|
6 Participants
n=740 Participants
|
2 Participants
n=1 Participants
|
6 Participants
n=80 Participants
|
2 Participants
n=94 Participants
|
6 Participants
n=27 Participants
|
2 Participants
n=29 Participants
|
9 Participants
n=2 Participants
|
3 Participants
n=30 Participants
|
7 Participants
n=3 Participants
|
3 Participants
n=13 Participants
|
62 Participants
n=13 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=39 Participants
|
0 Participants
n=29 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=185 Participants
|
0 Participants
n=740 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=80 Participants
|
0 Participants
n=94 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=29 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=13 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=39 Participants
|
0 Participants
n=29 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=185 Participants
|
0 Participants
n=740 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=80 Participants
|
0 Participants
n=94 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=29 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=13 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=29 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=185 Participants
|
0 Participants
n=740 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=80 Participants
|
0 Participants
n=94 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=29 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=13 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
0 Participants
n=29 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=185 Participants
|
0 Participants
n=740 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=80 Participants
|
0 Participants
n=94 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=29 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=13 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
0 Participants
n=29 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=185 Participants
|
0 Participants
n=740 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=80 Participants
|
0 Participants
n=94 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=29 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=13 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=39 Participants
|
0 Participants
n=29 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=185 Participants
|
1 Participants
n=740 Participants
|
0 Participants
n=1 Participants
|
2 Participants
n=80 Participants
|
1 Participants
n=94 Participants
|
2 Participants
n=27 Participants
|
0 Participants
n=29 Participants
|
1 Participants
n=2 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=13 Participants
|
9 Participants
n=13 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=39 Participants
|
2 Participants
n=29 Participants
|
6 Participants
n=60 Participants
|
2 Participants
n=185 Participants
|
5 Participants
n=740 Participants
|
2 Participants
n=1 Participants
|
4 Participants
n=80 Participants
|
1 Participants
n=94 Participants
|
4 Participants
n=27 Participants
|
2 Participants
n=29 Participants
|
8 Participants
n=2 Participants
|
3 Participants
n=30 Participants
|
7 Participants
n=3 Participants
|
2 Participants
n=13 Participants
|
53 Participants
n=13 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
0 Participants
n=29 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=185 Participants
|
0 Participants
n=740 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=80 Participants
|
0 Participants
n=94 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=29 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=13 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=29 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=185 Participants
|
0 Participants
n=740 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=80 Participants
|
0 Participants
n=94 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=29 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=13 Participants
|
PRIMARY outcome
Timeframe: Part 1: Day 1 through Day 5; Part 2: Day 1 through Day 26Adverse events will be analyzed for severity and potential relationship to PDM608 to determine safety and tolerability of PDM608
Outcome measures
| Measure |
Part 1 SAD SC PDM608 Cohort 3
n=6 Participants
Single SC administration dose of 3150 ug PDM608
|
Part 1 SAD SC Placebo Cohort 3
n=2 Participants
Single SC administration dose of 3150 ug Placebo
|
Part 1 SAD SC PDM608 Cohort 4
n=6 Participants
Single SC administration dose of 6300 ug PDM608
|
Part 1 SAD SC Placebo Cohort 4
n=2 Participants
Single SC administration dose of 6300 ug Placebo
|
Part 1 SAD SC PDM608 Cohort 5
n=6 Participants
Single SC administration dose of 12600 ug PDM608
|
Part 1 SAD SC Placebo Cohort 5
n=2 Participants
Single SC administration dose of 12600 ug Placebo
|
Part 2 MAD SC PDM608 Cohort 1
n=9 Participants
Once a week subcutaneous administration of 6300 ug of PDM608 for 4 weeks
|
Part 2 MAD SC Placebo Cohort 1
n=3 Participants
Once a week subcutaneous administration of 6300 ug of Placebo for 4 weeks
|
Part 2 MAD SC PDM608 Cohort 2
n=7 Participants
Once a week subcutaneous administration of 12600 ug of PDM608 for 4 weeks
|
Part 2 MAD SC PDM608 Placebo Cohort 2
n=3 Participants
Once a week subcutaneous administration of 12600 ug of Placebo for 4 weeks
|
Part 1 SAD SC PDM608 Cohort 1
n=6 Participants
Single SC administration dose of 350 ug PDM608
|
Part 1 SAD SC Placebo Cohort 1
n=2 Participants
Single SC administration dose of 350 ug Placebo
|
Part 1 SAD SC PDM608 Cohort 2
n=6 Participants
Single SC administration dose of 1050 ug PDM608
|
Part 1 SAD SC Placebo Cohort 2
n=2 Participants
Single SC administration dose of 1050 ug Placebo
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Adverse Events
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Part 1: Day 1 through Day 5; Part 2: Day 1 through Day 26Results outside of laboratory defined normal ranges will be analyzed for clinical significance and used to determine safety and tolerability of PDM608
Outcome measures
| Measure |
Part 1 SAD SC PDM608 Cohort 3
n=6 Participants
Single SC administration dose of 3150 ug PDM608
|
Part 1 SAD SC Placebo Cohort 3
n=2 Participants
Single SC administration dose of 3150 ug Placebo
|
Part 1 SAD SC PDM608 Cohort 4
n=6 Participants
Single SC administration dose of 6300 ug PDM608
|
Part 1 SAD SC Placebo Cohort 4
n=2 Participants
Single SC administration dose of 6300 ug Placebo
|
Part 1 SAD SC PDM608 Cohort 5
n=6 Participants
Single SC administration dose of 12600 ug PDM608
|
Part 1 SAD SC Placebo Cohort 5
n=2 Participants
Single SC administration dose of 12600 ug Placebo
|
Part 2 MAD SC PDM608 Cohort 1
n=9 Participants
Once a week subcutaneous administration of 6300 ug of PDM608 for 4 weeks
|
Part 2 MAD SC Placebo Cohort 1
n=3 Participants
Once a week subcutaneous administration of 6300 ug of Placebo for 4 weeks
|
Part 2 MAD SC PDM608 Cohort 2
n=7 Participants
Once a week subcutaneous administration of 12600 ug of PDM608 for 4 weeks
|
Part 2 MAD SC PDM608 Placebo Cohort 2
n=3 Participants
Once a week subcutaneous administration of 12600 ug of Placebo for 4 weeks
|
Part 1 SAD SC PDM608 Cohort 1
n=6 Participants
Single SC administration dose of 350 ug PDM608
|
Part 1 SAD SC Placebo Cohort 1
n=2 Participants
Single SC administration dose of 350 ug Placebo
|
Part 1 SAD SC PDM608 Cohort 2
n=6 Participants
Single SC administration dose of 1050 ug PDM608
|
Part 1 SAD SC Placebo Cohort 2
n=2 Participants
Single SC administration dose of 1050 ug Placebo
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Clinically Significant Abnormal Laboratory Test Results
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Part 1: Day 1 through Day 5; Part 2: Day 1 through Day 26Abnormal QTcF interval
Outcome measures
| Measure |
Part 1 SAD SC PDM608 Cohort 3
n=6 Participants
Single SC administration dose of 3150 ug PDM608
|
Part 1 SAD SC Placebo Cohort 3
n=2 Participants
Single SC administration dose of 3150 ug Placebo
|
Part 1 SAD SC PDM608 Cohort 4
n=6 Participants
Single SC administration dose of 6300 ug PDM608
|
Part 1 SAD SC Placebo Cohort 4
n=2 Participants
Single SC administration dose of 6300 ug Placebo
|
Part 1 SAD SC PDM608 Cohort 5
n=6 Participants
Single SC administration dose of 12600 ug PDM608
|
Part 1 SAD SC Placebo Cohort 5
n=2 Participants
Single SC administration dose of 12600 ug Placebo
|
Part 2 MAD SC PDM608 Cohort 1
n=9 Participants
Once a week subcutaneous administration of 6300 ug of PDM608 for 4 weeks
|
Part 2 MAD SC Placebo Cohort 1
n=3 Participants
Once a week subcutaneous administration of 6300 ug of Placebo for 4 weeks
|
Part 2 MAD SC PDM608 Cohort 2
n=7 Participants
Once a week subcutaneous administration of 12600 ug of PDM608 for 4 weeks
|
Part 2 MAD SC PDM608 Placebo Cohort 2
n=3 Participants
Once a week subcutaneous administration of 12600 ug of Placebo for 4 weeks
|
Part 1 SAD SC PDM608 Cohort 1
n=6 Participants
Single SC administration dose of 350 ug PDM608
|
Part 1 SAD SC Placebo Cohort 1
n=2 Participants
Single SC administration dose of 350 ug Placebo
|
Part 1 SAD SC PDM608 Cohort 2
n=6 Participants
Single SC administration dose of 1050 ug PDM608
|
Part 1 SAD SC Placebo Cohort 2
n=2 Participants
Single SC administration dose of 1050 ug Placebo
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Abnormal Electrocardiogram Readings: QTcF
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Part 1: Day 1 through Day 5; Part 2: Day 1 through Day 26Abnormal ventricular rate
Outcome measures
| Measure |
Part 1 SAD SC PDM608 Cohort 3
n=6 Participants
Single SC administration dose of 3150 ug PDM608
|
Part 1 SAD SC Placebo Cohort 3
n=2 Participants
Single SC administration dose of 3150 ug Placebo
|
Part 1 SAD SC PDM608 Cohort 4
n=6 Participants
Single SC administration dose of 6300 ug PDM608
|
Part 1 SAD SC Placebo Cohort 4
n=2 Participants
Single SC administration dose of 6300 ug Placebo
|
Part 1 SAD SC PDM608 Cohort 5
n=6 Participants
Single SC administration dose of 12600 ug PDM608
|
Part 1 SAD SC Placebo Cohort 5
n=2 Participants
Single SC administration dose of 12600 ug Placebo
|
Part 2 MAD SC PDM608 Cohort 1
n=9 Participants
Once a week subcutaneous administration of 6300 ug of PDM608 for 4 weeks
|
Part 2 MAD SC Placebo Cohort 1
n=3 Participants
Once a week subcutaneous administration of 6300 ug of Placebo for 4 weeks
|
Part 2 MAD SC PDM608 Cohort 2
n=7 Participants
Once a week subcutaneous administration of 12600 ug of PDM608 for 4 weeks
|
Part 2 MAD SC PDM608 Placebo Cohort 2
n=3 Participants
Once a week subcutaneous administration of 12600 ug of Placebo for 4 weeks
|
Part 1 SAD SC PDM608 Cohort 1
n=6 Participants
Single SC administration dose of 350 ug PDM608
|
Part 1 SAD SC Placebo Cohort 1
n=2 Participants
Single SC administration dose of 350 ug Placebo
|
Part 1 SAD SC PDM608 Cohort 2
n=6 Participants
Single SC administration dose of 1050 ug PDM608
|
Part 1 SAD SC Placebo Cohort 2
n=2 Participants
Single SC administration dose of 1050 ug Placebo
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Abnormal Electrocardiogram Readings: VR
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Part 1: Day 1 through Day 5; Part 2: Day 1 through Day 26Abnormal PR interval
Outcome measures
| Measure |
Part 1 SAD SC PDM608 Cohort 3
n=6 Participants
Single SC administration dose of 3150 ug PDM608
|
Part 1 SAD SC Placebo Cohort 3
n=2 Participants
Single SC administration dose of 3150 ug Placebo
|
Part 1 SAD SC PDM608 Cohort 4
n=6 Participants
Single SC administration dose of 6300 ug PDM608
|
Part 1 SAD SC Placebo Cohort 4
n=2 Participants
Single SC administration dose of 6300 ug Placebo
|
Part 1 SAD SC PDM608 Cohort 5
n=6 Participants
Single SC administration dose of 12600 ug PDM608
|
Part 1 SAD SC Placebo Cohort 5
n=2 Participants
Single SC administration dose of 12600 ug Placebo
|
Part 2 MAD SC PDM608 Cohort 1
n=9 Participants
Once a week subcutaneous administration of 6300 ug of PDM608 for 4 weeks
|
Part 2 MAD SC Placebo Cohort 1
n=3 Participants
Once a week subcutaneous administration of 6300 ug of Placebo for 4 weeks
|
Part 2 MAD SC PDM608 Cohort 2
n=7 Participants
Once a week subcutaneous administration of 12600 ug of PDM608 for 4 weeks
|
Part 2 MAD SC PDM608 Placebo Cohort 2
n=3 Participants
Once a week subcutaneous administration of 12600 ug of Placebo for 4 weeks
|
Part 1 SAD SC PDM608 Cohort 1
n=6 Participants
Single SC administration dose of 350 ug PDM608
|
Part 1 SAD SC Placebo Cohort 1
n=2 Participants
Single SC administration dose of 350 ug Placebo
|
Part 1 SAD SC PDM608 Cohort 2
n=6 Participants
Single SC administration dose of 1050 ug PDM608
|
Part 1 SAD SC Placebo Cohort 2
n=2 Participants
Single SC administration dose of 1050 ug Placebo
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Abnormal Electrocardiogram Readings: PR Interval
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Part 1: Day 1 through Day 5; Part 2: Day 1 through Day 26Abnormal QRS duration
Outcome measures
| Measure |
Part 1 SAD SC PDM608 Cohort 3
n=6 Participants
Single SC administration dose of 3150 ug PDM608
|
Part 1 SAD SC Placebo Cohort 3
n=2 Participants
Single SC administration dose of 3150 ug Placebo
|
Part 1 SAD SC PDM608 Cohort 4
n=6 Participants
Single SC administration dose of 6300 ug PDM608
|
Part 1 SAD SC Placebo Cohort 4
n=2 Participants
Single SC administration dose of 6300 ug Placebo
|
Part 1 SAD SC PDM608 Cohort 5
n=6 Participants
Single SC administration dose of 12600 ug PDM608
|
Part 1 SAD SC Placebo Cohort 5
n=2 Participants
Single SC administration dose of 12600 ug Placebo
|
Part 2 MAD SC PDM608 Cohort 1
n=9 Participants
Once a week subcutaneous administration of 6300 ug of PDM608 for 4 weeks
|
Part 2 MAD SC Placebo Cohort 1
n=3 Participants
Once a week subcutaneous administration of 6300 ug of Placebo for 4 weeks
|
Part 2 MAD SC PDM608 Cohort 2
n=7 Participants
Once a week subcutaneous administration of 12600 ug of PDM608 for 4 weeks
|
Part 2 MAD SC PDM608 Placebo Cohort 2
n=3 Participants
Once a week subcutaneous administration of 12600 ug of Placebo for 4 weeks
|
Part 1 SAD SC PDM608 Cohort 1
n=6 Participants
Single SC administration dose of 350 ug PDM608
|
Part 1 SAD SC Placebo Cohort 1
n=2 Participants
Single SC administration dose of 350 ug Placebo
|
Part 1 SAD SC PDM608 Cohort 2
n=6 Participants
Single SC administration dose of 1050 ug PDM608
|
Part 1 SAD SC Placebo Cohort 2
n=2 Participants
Single SC administration dose of 1050 ug Placebo
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Abnormal Electrocardiogram Readings: QRS Duration
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Part 1: Day 1 through Day 5; Part 2: Day 1 through Day 26Abnormal QRS axis
Outcome measures
| Measure |
Part 1 SAD SC PDM608 Cohort 3
n=6 Participants
Single SC administration dose of 3150 ug PDM608
|
Part 1 SAD SC Placebo Cohort 3
n=2 Participants
Single SC administration dose of 3150 ug Placebo
|
Part 1 SAD SC PDM608 Cohort 4
n=6 Participants
Single SC administration dose of 6300 ug PDM608
|
Part 1 SAD SC Placebo Cohort 4
n=2 Participants
Single SC administration dose of 6300 ug Placebo
|
Part 1 SAD SC PDM608 Cohort 5
n=6 Participants
Single SC administration dose of 12600 ug PDM608
|
Part 1 SAD SC Placebo Cohort 5
n=2 Participants
Single SC administration dose of 12600 ug Placebo
|
Part 2 MAD SC PDM608 Cohort 1
n=9 Participants
Once a week subcutaneous administration of 6300 ug of PDM608 for 4 weeks
|
Part 2 MAD SC Placebo Cohort 1
n=3 Participants
Once a week subcutaneous administration of 6300 ug of Placebo for 4 weeks
|
Part 2 MAD SC PDM608 Cohort 2
n=7 Participants
Once a week subcutaneous administration of 12600 ug of PDM608 for 4 weeks
|
Part 2 MAD SC PDM608 Placebo Cohort 2
n=3 Participants
Once a week subcutaneous administration of 12600 ug of Placebo for 4 weeks
|
Part 1 SAD SC PDM608 Cohort 1
n=6 Participants
Single SC administration dose of 350 ug PDM608
|
Part 1 SAD SC Placebo Cohort 1
n=2 Participants
Single SC administration dose of 350 ug Placebo
|
Part 1 SAD SC PDM608 Cohort 2
n=6 Participants
Single SC administration dose of 1050 ug PDM608
|
Part 1 SAD SC Placebo Cohort 2
n=2 Participants
Single SC administration dose of 1050 ug Placebo
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Abnormal Electrocardiogram Readings: QRS Axis
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Part 1: Day 1 through Day 5; Part 2: Day 1 through Day 26Abnormal systolic and/or diastolic pressure (mmHg)
Outcome measures
| Measure |
Part 1 SAD SC PDM608 Cohort 3
n=6 Participants
Single SC administration dose of 3150 ug PDM608
|
Part 1 SAD SC Placebo Cohort 3
n=2 Participants
Single SC administration dose of 3150 ug Placebo
|
Part 1 SAD SC PDM608 Cohort 4
n=6 Participants
Single SC administration dose of 6300 ug PDM608
|
Part 1 SAD SC Placebo Cohort 4
n=2 Participants
Single SC administration dose of 6300 ug Placebo
|
Part 1 SAD SC PDM608 Cohort 5
n=6 Participants
Single SC administration dose of 12600 ug PDM608
|
Part 1 SAD SC Placebo Cohort 5
n=2 Participants
Single SC administration dose of 12600 ug Placebo
|
Part 2 MAD SC PDM608 Cohort 1
n=9 Participants
Once a week subcutaneous administration of 6300 ug of PDM608 for 4 weeks
|
Part 2 MAD SC Placebo Cohort 1
n=3 Participants
Once a week subcutaneous administration of 6300 ug of Placebo for 4 weeks
|
Part 2 MAD SC PDM608 Cohort 2
n=7 Participants
Once a week subcutaneous administration of 12600 ug of PDM608 for 4 weeks
|
Part 2 MAD SC PDM608 Placebo Cohort 2
n=3 Participants
Once a week subcutaneous administration of 12600 ug of Placebo for 4 weeks
|
Part 1 SAD SC PDM608 Cohort 1
n=6 Participants
Single SC administration dose of 350 ug PDM608
|
Part 1 SAD SC Placebo Cohort 1
n=2 Participants
Single SC administration dose of 350 ug Placebo
|
Part 1 SAD SC PDM608 Cohort 2
n=6 Participants
Single SC administration dose of 1050 ug PDM608
|
Part 1 SAD SC Placebo Cohort 2
n=2 Participants
Single SC administration dose of 1050 ug Placebo
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Abnormal Vital Signs: BP
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Part 1: Day 1 through Day 5; Part 2: Day 1 through Day 26Abnormal heart rate (beats/minute)
Outcome measures
| Measure |
Part 1 SAD SC PDM608 Cohort 3
n=6 Participants
Single SC administration dose of 3150 ug PDM608
|
Part 1 SAD SC Placebo Cohort 3
n=2 Participants
Single SC administration dose of 3150 ug Placebo
|
Part 1 SAD SC PDM608 Cohort 4
n=6 Participants
Single SC administration dose of 6300 ug PDM608
|
Part 1 SAD SC Placebo Cohort 4
n=2 Participants
Single SC administration dose of 6300 ug Placebo
|
Part 1 SAD SC PDM608 Cohort 5
n=6 Participants
Single SC administration dose of 12600 ug PDM608
|
Part 1 SAD SC Placebo Cohort 5
n=2 Participants
Single SC administration dose of 12600 ug Placebo
|
Part 2 MAD SC PDM608 Cohort 1
n=9 Participants
Once a week subcutaneous administration of 6300 ug of PDM608 for 4 weeks
|
Part 2 MAD SC Placebo Cohort 1
n=3 Participants
Once a week subcutaneous administration of 6300 ug of Placebo for 4 weeks
|
Part 2 MAD SC PDM608 Cohort 2
n=7 Participants
Once a week subcutaneous administration of 12600 ug of PDM608 for 4 weeks
|
Part 2 MAD SC PDM608 Placebo Cohort 2
n=3 Participants
Once a week subcutaneous administration of 12600 ug of Placebo for 4 weeks
|
Part 1 SAD SC PDM608 Cohort 1
n=6 Participants
Single SC administration dose of 350 ug PDM608
|
Part 1 SAD SC Placebo Cohort 1
n=2 Participants
Single SC administration dose of 350 ug Placebo
|
Part 1 SAD SC PDM608 Cohort 2
n=6 Participants
Single SC administration dose of 1050 ug PDM608
|
Part 1 SAD SC Placebo Cohort 2
n=2 Participants
Single SC administration dose of 1050 ug Placebo
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Abnormal Vital Signs: HR
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Part 1: Day 1 through Day 5; Part 2: Day 1 through Day 26Abnormal body temperature (Celsius)
Outcome measures
| Measure |
Part 1 SAD SC PDM608 Cohort 3
n=6 Participants
Single SC administration dose of 3150 ug PDM608
|
Part 1 SAD SC Placebo Cohort 3
n=2 Participants
Single SC administration dose of 3150 ug Placebo
|
Part 1 SAD SC PDM608 Cohort 4
n=6 Participants
Single SC administration dose of 6300 ug PDM608
|
Part 1 SAD SC Placebo Cohort 4
n=2 Participants
Single SC administration dose of 6300 ug Placebo
|
Part 1 SAD SC PDM608 Cohort 5
n=6 Participants
Single SC administration dose of 12600 ug PDM608
|
Part 1 SAD SC Placebo Cohort 5
n=2 Participants
Single SC administration dose of 12600 ug Placebo
|
Part 2 MAD SC PDM608 Cohort 1
n=9 Participants
Once a week subcutaneous administration of 6300 ug of PDM608 for 4 weeks
|
Part 2 MAD SC Placebo Cohort 1
n=3 Participants
Once a week subcutaneous administration of 6300 ug of Placebo for 4 weeks
|
Part 2 MAD SC PDM608 Cohort 2
n=7 Participants
Once a week subcutaneous administration of 12600 ug of PDM608 for 4 weeks
|
Part 2 MAD SC PDM608 Placebo Cohort 2
n=3 Participants
Once a week subcutaneous administration of 12600 ug of Placebo for 4 weeks
|
Part 1 SAD SC PDM608 Cohort 1
n=6 Participants
Single SC administration dose of 350 ug PDM608
|
Part 1 SAD SC Placebo Cohort 1
n=2 Participants
Single SC administration dose of 350 ug Placebo
|
Part 1 SAD SC PDM608 Cohort 2
n=6 Participants
Single SC administration dose of 1050 ug PDM608
|
Part 1 SAD SC Placebo Cohort 2
n=2 Participants
Single SC administration dose of 1050 ug Placebo
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Abnormal Vital Signs: Temp
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Part 1: Day 1 through Day 5; Part 2: Day 1 through Day 26Abnormal respiratory rate (breaths/minute)
Outcome measures
| Measure |
Part 1 SAD SC PDM608 Cohort 3
n=6 Participants
Single SC administration dose of 3150 ug PDM608
|
Part 1 SAD SC Placebo Cohort 3
n=2 Participants
Single SC administration dose of 3150 ug Placebo
|
Part 1 SAD SC PDM608 Cohort 4
n=6 Participants
Single SC administration dose of 6300 ug PDM608
|
Part 1 SAD SC Placebo Cohort 4
n=2 Participants
Single SC administration dose of 6300 ug Placebo
|
Part 1 SAD SC PDM608 Cohort 5
n=6 Participants
Single SC administration dose of 12600 ug PDM608
|
Part 1 SAD SC Placebo Cohort 5
n=2 Participants
Single SC administration dose of 12600 ug Placebo
|
Part 2 MAD SC PDM608 Cohort 1
n=9 Participants
Once a week subcutaneous administration of 6300 ug of PDM608 for 4 weeks
|
Part 2 MAD SC Placebo Cohort 1
n=3 Participants
Once a week subcutaneous administration of 6300 ug of Placebo for 4 weeks
|
Part 2 MAD SC PDM608 Cohort 2
n=7 Participants
Once a week subcutaneous administration of 12600 ug of PDM608 for 4 weeks
|
Part 2 MAD SC PDM608 Placebo Cohort 2
n=3 Participants
Once a week subcutaneous administration of 12600 ug of Placebo for 4 weeks
|
Part 1 SAD SC PDM608 Cohort 1
n=6 Participants
Single SC administration dose of 350 ug PDM608
|
Part 1 SAD SC Placebo Cohort 1
n=2 Participants
Single SC administration dose of 350 ug Placebo
|
Part 1 SAD SC PDM608 Cohort 2
n=6 Participants
Single SC administration dose of 1050 ug PDM608
|
Part 1 SAD SC Placebo Cohort 2
n=2 Participants
Single SC administration dose of 1050 ug Placebo
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Abnormal Vital Signs: RR
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Part 1: Day 1 through Day 5; Part 2: Day 1 through Day 26Physical exams will include evaluation of general appearance, head, neck, thyroid, eyes, ears, nose and throat, respiratory, cardiovascular, abdomen, dermatological, genitourinary, musculoskeletal and neurological systems
Outcome measures
| Measure |
Part 1 SAD SC PDM608 Cohort 3
n=6 Participants
Single SC administration dose of 3150 ug PDM608
|
Part 1 SAD SC Placebo Cohort 3
n=2 Participants
Single SC administration dose of 3150 ug Placebo
|
Part 1 SAD SC PDM608 Cohort 4
n=6 Participants
Single SC administration dose of 6300 ug PDM608
|
Part 1 SAD SC Placebo Cohort 4
n=2 Participants
Single SC administration dose of 6300 ug Placebo
|
Part 1 SAD SC PDM608 Cohort 5
n=6 Participants
Single SC administration dose of 12600 ug PDM608
|
Part 1 SAD SC Placebo Cohort 5
n=2 Participants
Single SC administration dose of 12600 ug Placebo
|
Part 2 MAD SC PDM608 Cohort 1
n=9 Participants
Once a week subcutaneous administration of 6300 ug of PDM608 for 4 weeks
|
Part 2 MAD SC Placebo Cohort 1
n=3 Participants
Once a week subcutaneous administration of 6300 ug of Placebo for 4 weeks
|
Part 2 MAD SC PDM608 Cohort 2
n=7 Participants
Once a week subcutaneous administration of 12600 ug of PDM608 for 4 weeks
|
Part 2 MAD SC PDM608 Placebo Cohort 2
n=3 Participants
Once a week subcutaneous administration of 12600 ug of Placebo for 4 weeks
|
Part 1 SAD SC PDM608 Cohort 1
n=6 Participants
Single SC administration dose of 350 ug PDM608
|
Part 1 SAD SC Placebo Cohort 1
n=2 Participants
Single SC administration dose of 350 ug Placebo
|
Part 1 SAD SC PDM608 Cohort 2
n=6 Participants
Single SC administration dose of 1050 ug PDM608
|
Part 1 SAD SC Placebo Cohort 2
n=2 Participants
Single SC administration dose of 1050 ug Placebo
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Abnormal Physical Exams
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Part 1: Day 1 through Day 5; Part 2: Day 1 through Day 26Population: Cmax for subjects dosed with PDM608 Following a single SC administration of PDM608 at dose levels of 350 μg (cohort 1) and 1050 μg (cohort 2), serum concentrations of PDM608 were BLQ (\<10.0 ng/mL) for all subjects and time points.
Analysis of PDM608 plasma concentration data will be performed using PK parameters.
Outcome measures
| Measure |
Part 1 SAD SC PDM608 Cohort 3
n=6 Participants
Single SC administration dose of 3150 ug PDM608
|
Part 1 SAD SC Placebo Cohort 3
n=9 Participants
Single SC administration dose of 3150 ug Placebo
|
Part 1 SAD SC PDM608 Cohort 4
n=9 Participants
Single SC administration dose of 6300 ug PDM608
|
Part 1 SAD SC Placebo Cohort 4
n=8 Participants
Single SC administration dose of 6300 ug Placebo
|
Part 1 SAD SC PDM608 Cohort 5
n=8 Participants
Single SC administration dose of 12600 ug PDM608
|
Part 1 SAD SC Placebo Cohort 5
Single SC administration dose of 12600 ug Placebo
|
Part 2 MAD SC PDM608 Cohort 1
Once a week subcutaneous administration of 6300 ug of PDM608 for 4 weeks
|
Part 2 MAD SC Placebo Cohort 1
Once a week subcutaneous administration of 6300 ug of Placebo for 4 weeks
|
Part 2 MAD SC PDM608 Cohort 2
Once a week subcutaneous administration of 12600 ug of PDM608 for 4 weeks
|
Part 2 MAD SC PDM608 Placebo Cohort 2
Once a week subcutaneous administration of 12600 ug of Placebo for 4 weeks
|
Part 1 SAD SC PDM608 Cohort 1
n=6 Participants
Single SC administration dose of 350 ug PDM608
|
Part 1 SAD SC Placebo Cohort 1
n=6 Participants
Single SC administration dose of 350 ug Placebo
|
Part 1 SAD SC PDM608 Cohort 2
n=6 Participants
Single SC administration dose of 1050 ug PDM608
|
Part 1 SAD SC Placebo Cohort 2
n=6 Participants
Single SC administration dose of 1050 ug Placebo
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Assess PK Parameters for Single (Part 1) and Multiple (Part 2) SC Doses of PDM608 in Healthy Volunteers.
|
203 ng/mL
Geometric Coefficient of Variation 70.5
|
44.2 ng/mL
Geometric Coefficient of Variation 60.2
|
21.9 ng/mL
Geometric Coefficient of Variation 247.9
|
150 ng/mL
Geometric Coefficient of Variation 0
|
10.7 ng/mL
Geometric Coefficient of Variation 0
|
—
|
—
|
—
|
—
|
—
|
NA ng/mL
Geometric Coefficient of Variation NA
below the level of detection
|
NA ng/mL
Geometric Coefficient of Variation NA
below the level of detection
|
23.4 ng/mL
Geometric Coefficient of Variation 52.2
|
52.4 ng/mL
Geometric Coefficient of Variation 96.4
|
SECONDARY outcome
Timeframe: Part 1: Day 1 through Day 22; Part 2: Day 1 through Day 60Population: The Number of Participants with Positive Anti-Drug Antibodies. Data was not collected for SAD cohorts for 144 and 912 hours pose dose. Data was not collected for MAD cohorts 1-2 for 336 and 504 hours post dose.
Incidence of ADA in blood
Outcome measures
| Measure |
Part 1 SAD SC PDM608 Cohort 3
n=6 Participants
Single SC administration dose of 3150 ug PDM608
|
Part 1 SAD SC Placebo Cohort 3
n=9 Participants
Single SC administration dose of 3150 ug Placebo
|
Part 1 SAD SC PDM608 Cohort 4
n=9 Participants
Single SC administration dose of 6300 ug PDM608
|
Part 1 SAD SC Placebo Cohort 4
Single SC administration dose of 6300 ug Placebo
|
Part 1 SAD SC PDM608 Cohort 5
Single SC administration dose of 12600 ug PDM608
|
Part 1 SAD SC Placebo Cohort 5
Single SC administration dose of 12600 ug Placebo
|
Part 2 MAD SC PDM608 Cohort 1
Once a week subcutaneous administration of 6300 ug of PDM608 for 4 weeks
|
Part 2 MAD SC Placebo Cohort 1
Once a week subcutaneous administration of 6300 ug of Placebo for 4 weeks
|
Part 2 MAD SC PDM608 Cohort 2
Once a week subcutaneous administration of 12600 ug of PDM608 for 4 weeks
|
Part 2 MAD SC PDM608 Placebo Cohort 2
Once a week subcutaneous administration of 12600 ug of Placebo for 4 weeks
|
Part 1 SAD SC PDM608 Cohort 1
n=6 Participants
Single SC administration dose of 350 ug PDM608
|
Part 1 SAD SC Placebo Cohort 1
n=6 Participants
Single SC administration dose of 350 ug Placebo
|
Part 1 SAD SC PDM608 Cohort 2
n=6 Participants
Single SC administration dose of 1050 ug PDM608
|
Part 1 SAD SC Placebo Cohort 2
n=6 Participants
Single SC administration dose of 1050 ug Placebo
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
To Assess Immunogenicity Following Single and Multiple Doses of PDM608
336 hours post-dose
|
6 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
4 participants
|
6 participants
|
5 participants
|
5 participants
|
|
To Assess Immunogenicity Following Single and Multiple Doses of PDM608
504 hours post-dose
|
6 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
4 participants
|
5 participants
|
5 participants
|
6 participants
|
|
To Assess Immunogenicity Following Single and Multiple Doses of PDM608
Day 28 (144 hours post-dose)
|
—
|
9 participants
|
7 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
To Assess Immunogenicity Following Single and Multiple Doses of PDM608
Day 60 (912 hours post-dose)
|
—
|
7 participants
|
7 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Part 1 SAD SC Placebo Cohort 4
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Part 1 SAD SC PDM608 Cohort 5
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Part 1 SAD SC Placebo Cohort 5
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Part 2 MAD SC PDM608 Cohort 1
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Part 2 MAD SC Placebo Cohort 1
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Part 2 MAD SC PDM608 Cohort 2
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Part 2 MAD SC Placebo Cohort 2
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Part 1 SAD SC PDM608 Cohort 1
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Part 1 SAD SC Placebo Cohort 1
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Part 1 SAD SC PDM608 Cohort 2
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Part 1 SAD SC Placebo Cohort 2
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Part 1 SAD SC PDM608 Cohort 3
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Part 1 SAD SC Placebo Cohort 3
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Part 1 SAD SC PDM608 Cohort 4
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Part 1 SAD SC Placebo Cohort 4
n=2 participants at risk
Single SC administration dose of 6300 ug Placebo
|
Part 1 SAD SC PDM608 Cohort 5
n=6 participants at risk
Single SC administration dose of 12600 ug PDM608
|
Part 1 SAD SC Placebo Cohort 5
n=2 participants at risk
Single SC administration dose of 12600 ug Placebo
|
Part 2 MAD SC PDM608 Cohort 1
n=9 participants at risk
Once a week subcutaneous administration of 6300 ug of PDM608 for 4 weeks
|
Part 2 MAD SC Placebo Cohort 1
n=3 participants at risk
Once a week subcutaneous administration of 6300 ug of Placebo for 4 weeks
|
Part 2 MAD SC PDM608 Cohort 2
n=9 participants at risk
Once a week subcutaneous administration of 12600 ug of PDM608 for 4 weeks
|
Part 2 MAD SC Placebo Cohort 2
n=3 participants at risk
Once a week subcutaneous administration of 12600 ug of Placebo for 4 weeks
|
Part 1 SAD SC PDM608 Cohort 1
n=6 participants at risk
Single SC administration dose of 350 ug PDM608
|
Part 1 SAD SC Placebo Cohort 1
n=2 participants at risk
Single SC administration dose of 350 ug Placebo
|
Part 1 SAD SC PDM608 Cohort 2
n=6 participants at risk
Single SC administration dose of 1050 ug PDM608
|
Part 1 SAD SC Placebo Cohort 2
n=2 participants at risk
Single SC administration dose of 1050 ug Placebo
|
Part 1 SAD SC PDM608 Cohort 3
n=6 participants at risk
Single SC administration dose of 3150 ug PDM608
|
Part 1 SAD SC Placebo Cohort 3
n=2 participants at risk
Single SC administration dose of 3150 ug Placebo
|
Part 1 SAD SC PDM608 Cohort 4
n=6 participants at risk
Single SC administration dose of 6300 ug PDM608
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Injection Site Reactions
|
0.00%
0/2 • Adverse events was collected from the time of consent to 30 days after the last dose of study drug. For Part 1, duration of study participation is 22 days with PDM608/Placebo administered on Day 1. Study duration for Part 2 is 60 with the last dose of PDM608/Placebo administered on Day 22. If subjects have ongoing AEs at the end of study visit, the study team contacted the subjects weekly until AE resolution.
During each study visit, subjects were questioned directly regarding occurrence of any adverse medical event. All AEs were documented in the EDC, including date, time of onset, description of AE, severity, seriousness, duration, actions taken, outcome and an investigator's opinion on relationship between study drug.
|
100.0%
6/6 • Number of events 8 • Adverse events was collected from the time of consent to 30 days after the last dose of study drug. For Part 1, duration of study participation is 22 days with PDM608/Placebo administered on Day 1. Study duration for Part 2 is 60 with the last dose of PDM608/Placebo administered on Day 22. If subjects have ongoing AEs at the end of study visit, the study team contacted the subjects weekly until AE resolution.
During each study visit, subjects were questioned directly regarding occurrence of any adverse medical event. All AEs were documented in the EDC, including date, time of onset, description of AE, severity, seriousness, duration, actions taken, outcome and an investigator's opinion on relationship between study drug.
|
0.00%
0/2 • Adverse events was collected from the time of consent to 30 days after the last dose of study drug. For Part 1, duration of study participation is 22 days with PDM608/Placebo administered on Day 1. Study duration for Part 2 is 60 with the last dose of PDM608/Placebo administered on Day 22. If subjects have ongoing AEs at the end of study visit, the study team contacted the subjects weekly until AE resolution.
During each study visit, subjects were questioned directly regarding occurrence of any adverse medical event. All AEs were documented in the EDC, including date, time of onset, description of AE, severity, seriousness, duration, actions taken, outcome and an investigator's opinion on relationship between study drug.
|
100.0%
9/9 • Number of events 34 • Adverse events was collected from the time of consent to 30 days after the last dose of study drug. For Part 1, duration of study participation is 22 days with PDM608/Placebo administered on Day 1. Study duration for Part 2 is 60 with the last dose of PDM608/Placebo administered on Day 22. If subjects have ongoing AEs at the end of study visit, the study team contacted the subjects weekly until AE resolution.
During each study visit, subjects were questioned directly regarding occurrence of any adverse medical event. All AEs were documented in the EDC, including date, time of onset, description of AE, severity, seriousness, duration, actions taken, outcome and an investigator's opinion on relationship between study drug.
|
66.7%
2/3 • Number of events 3 • Adverse events was collected from the time of consent to 30 days after the last dose of study drug. For Part 1, duration of study participation is 22 days with PDM608/Placebo administered on Day 1. Study duration for Part 2 is 60 with the last dose of PDM608/Placebo administered on Day 22. If subjects have ongoing AEs at the end of study visit, the study team contacted the subjects weekly until AE resolution.
During each study visit, subjects were questioned directly regarding occurrence of any adverse medical event. All AEs were documented in the EDC, including date, time of onset, description of AE, severity, seriousness, duration, actions taken, outcome and an investigator's opinion on relationship between study drug.
|
100.0%
9/9 • Number of events 35 • Adverse events was collected from the time of consent to 30 days after the last dose of study drug. For Part 1, duration of study participation is 22 days with PDM608/Placebo administered on Day 1. Study duration for Part 2 is 60 with the last dose of PDM608/Placebo administered on Day 22. If subjects have ongoing AEs at the end of study visit, the study team contacted the subjects weekly until AE resolution.
During each study visit, subjects were questioned directly regarding occurrence of any adverse medical event. All AEs were documented in the EDC, including date, time of onset, description of AE, severity, seriousness, duration, actions taken, outcome and an investigator's opinion on relationship between study drug.
|
66.7%
2/3 • Number of events 2 • Adverse events was collected from the time of consent to 30 days after the last dose of study drug. For Part 1, duration of study participation is 22 days with PDM608/Placebo administered on Day 1. Study duration for Part 2 is 60 with the last dose of PDM608/Placebo administered on Day 22. If subjects have ongoing AEs at the end of study visit, the study team contacted the subjects weekly until AE resolution.
During each study visit, subjects were questioned directly regarding occurrence of any adverse medical event. All AEs were documented in the EDC, including date, time of onset, description of AE, severity, seriousness, duration, actions taken, outcome and an investigator's opinion on relationship between study drug.
|
83.3%
5/6 • Number of events 5 • Adverse events was collected from the time of consent to 30 days after the last dose of study drug. For Part 1, duration of study participation is 22 days with PDM608/Placebo administered on Day 1. Study duration for Part 2 is 60 with the last dose of PDM608/Placebo administered on Day 22. If subjects have ongoing AEs at the end of study visit, the study team contacted the subjects weekly until AE resolution.
During each study visit, subjects were questioned directly regarding occurrence of any adverse medical event. All AEs were documented in the EDC, including date, time of onset, description of AE, severity, seriousness, duration, actions taken, outcome and an investigator's opinion on relationship between study drug.
|
0.00%
0/2 • Adverse events was collected from the time of consent to 30 days after the last dose of study drug. For Part 1, duration of study participation is 22 days with PDM608/Placebo administered on Day 1. Study duration for Part 2 is 60 with the last dose of PDM608/Placebo administered on Day 22. If subjects have ongoing AEs at the end of study visit, the study team contacted the subjects weekly until AE resolution.
During each study visit, subjects were questioned directly regarding occurrence of any adverse medical event. All AEs were documented in the EDC, including date, time of onset, description of AE, severity, seriousness, duration, actions taken, outcome and an investigator's opinion on relationship between study drug.
|
83.3%
5/6 • Number of events 9 • Adverse events was collected from the time of consent to 30 days after the last dose of study drug. For Part 1, duration of study participation is 22 days with PDM608/Placebo administered on Day 1. Study duration for Part 2 is 60 with the last dose of PDM608/Placebo administered on Day 22. If subjects have ongoing AEs at the end of study visit, the study team contacted the subjects weekly until AE resolution.
During each study visit, subjects were questioned directly regarding occurrence of any adverse medical event. All AEs were documented in the EDC, including date, time of onset, description of AE, severity, seriousness, duration, actions taken, outcome and an investigator's opinion on relationship between study drug.
|
50.0%
1/2 • Number of events 1 • Adverse events was collected from the time of consent to 30 days after the last dose of study drug. For Part 1, duration of study participation is 22 days with PDM608/Placebo administered on Day 1. Study duration for Part 2 is 60 with the last dose of PDM608/Placebo administered on Day 22. If subjects have ongoing AEs at the end of study visit, the study team contacted the subjects weekly until AE resolution.
During each study visit, subjects were questioned directly regarding occurrence of any adverse medical event. All AEs were documented in the EDC, including date, time of onset, description of AE, severity, seriousness, duration, actions taken, outcome and an investigator's opinion on relationship between study drug.
|
66.7%
4/6 • Number of events 8 • Adverse events was collected from the time of consent to 30 days after the last dose of study drug. For Part 1, duration of study participation is 22 days with PDM608/Placebo administered on Day 1. Study duration for Part 2 is 60 with the last dose of PDM608/Placebo administered on Day 22. If subjects have ongoing AEs at the end of study visit, the study team contacted the subjects weekly until AE resolution.
During each study visit, subjects were questioned directly regarding occurrence of any adverse medical event. All AEs were documented in the EDC, including date, time of onset, description of AE, severity, seriousness, duration, actions taken, outcome and an investigator's opinion on relationship between study drug.
|
0.00%
0/2 • Adverse events was collected from the time of consent to 30 days after the last dose of study drug. For Part 1, duration of study participation is 22 days with PDM608/Placebo administered on Day 1. Study duration for Part 2 is 60 with the last dose of PDM608/Placebo administered on Day 22. If subjects have ongoing AEs at the end of study visit, the study team contacted the subjects weekly until AE resolution.
During each study visit, subjects were questioned directly regarding occurrence of any adverse medical event. All AEs were documented in the EDC, including date, time of onset, description of AE, severity, seriousness, duration, actions taken, outcome and an investigator's opinion on relationship between study drug.
|
100.0%
6/6 • Number of events 10 • Adverse events was collected from the time of consent to 30 days after the last dose of study drug. For Part 1, duration of study participation is 22 days with PDM608/Placebo administered on Day 1. Study duration for Part 2 is 60 with the last dose of PDM608/Placebo administered on Day 22. If subjects have ongoing AEs at the end of study visit, the study team contacted the subjects weekly until AE resolution.
During each study visit, subjects were questioned directly regarding occurrence of any adverse medical event. All AEs were documented in the EDC, including date, time of onset, description of AE, severity, seriousness, duration, actions taken, outcome and an investigator's opinion on relationship between study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place