Trial Outcomes & Findings for Clinical Study of ALT-BB4 to Determine Tolerance, Safety and Pharmacokinetics in Healthy Volunteer (NCT NCT05232175)
NCT ID: NCT05232175
Last Updated: 2026-01-29
Results Overview
Subject developing either immediate or delayed allergic reaction are considered to have drug allergy.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
290 participants
Primary outcome timeframe
2 days
Results posted on
2026-01-29
Participant Flow
Study was conducted in four sites in the Republic of Korea from January 18, 2022, to August 24, 2022.
The study consisted of Part I and Part Ⅱ, and a total of 244 participants received study treatments. Among the 290 enrolled participants, 46 were excluded from the Part 1 safety analysis due to an injection-site randomization error.
Unit of analysis: Forearms
Participant milestones
| Measure |
All Study Participants
PartⅠ(Allergy assessment): Participants were randomly assigned to receive intradermal administrations of ALT-BB4 or placebo into either the right or left forearm.
Part Ⅱ-A (PK assessment): Participants in Part Ⅱ-A included only subjects who had a negative drug allergy in the PartⅠ.
ALT-BB4 was administered subcutaneously into either the left or right upper arm.
PartⅡ-B (Safety assessment): Participants in Part Ⅱ-B included only subjects who had a negative drug allergy in the PartⅠ.
Enrolled subjects were randomized in a 2:1 ratio to receive ALT-BB4 or the comparator.
Investigator products (IP) were administered subcutaneously into either the right or left upper arm.
|
|---|---|
|
Part I (Allergy assessment)
STARTED
|
244 488
|
|
Part I (Allergy assessment)
ALT-BB4
|
244 244
|
|
Part I (Allergy assessment)
Placebo
|
244 244
|
|
Part I (Allergy assessment)
COMPLETED
|
244 488
|
|
Part I (Allergy assessment)
NOT COMPLETED
|
0 0
|
|
Part Ⅱ-A (PK assessment)
STARTED
|
23 23
|
|
Part Ⅱ-A (PK assessment)
COMPLETED
|
23 23
|
|
Part Ⅱ-A (PK assessment)
NOT COMPLETED
|
0 0
|
|
PartⅡ-B (Safety assessment)
STARTED
|
214 214
|
|
PartⅡ-B (Safety assessment)
ALT-BB4
|
142 142
|
|
PartⅡ-B (Safety assessment)
Placebo
|
72 72
|
|
PartⅡ-B (Safety assessment)
COMPLETED
|
214 214
|
|
PartⅡ-B (Safety assessment)
NOT COMPLETED
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Clinical Study of ALT-BB4 to Determine Tolerance, Safety and Pharmacokinetics in Healthy Volunteer
Baseline characteristics by cohort
| Measure |
All Study Participants
n=244 Participants
Participants were randomly assigned to receive intradermal administrations of ALT-BB4 or placebo into either the right or left forearm.
Participants in Part Ⅱ-A included only subjects who had a negative drug allergy in the PartⅠ.
ALT-BB4 was administered subcutaneously into either the left or right upper arm.
Participants in Part Ⅱ-B included only subjects who had a negative drug allergy in the PartⅠ.
Enrolled subjects were randomized in a 2:1 ratio to receive ALT-BB4 or the comparator.
Investigator products (IP) were administered subcutaneously into either the right or left upper arm.
|
|---|---|
|
Sex: Female, Male
Female
|
148 Participants
n=41 Participants
|
|
Sex: Female, Male
Male
|
96 Participants
n=41 Participants
|
|
BMI
|
23.5 (Kg/m2)
STANDARD_DEVIATION 3.6 • n=41 Participants
|
|
Age, Customized
Age
|
34.3 Years
STANDARD_DEVIATION 10 • n=41 Participants
|
|
Race/Ethnicity, Customized
Asian
|
244 Participants
n=41 Participants
|
PRIMARY outcome
Timeframe: 2 daysSubject developing either immediate or delayed allergic reaction are considered to have drug allergy.
Outcome measures
| Measure |
ALT-BB4
n=244 Participants
Participants were randomly assigned to receive intradermal administrations of ALT-BB4 or placebo into either the right or left forearm.
|
Placebo
n=244 Participants
Participants were randomly assigned to receive intradermal administrations of ALT-BB4 or placebo into either the right or left forearm.
|
|---|---|---|
|
Incidence Rate of Drug Allergy Following ID Injection of the IP
Delayed Drug Allergy Reaction (occurred within 48 hours)
|
1 Participants
|
0 Participants
|
|
Incidence Rate of Drug Allergy Following ID Injection of the IP
Immediate Drug Allergy Reaction (occurred within 30 minutes)
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 4 weeksPopulation: In PartⅡ-B, injection site TEAEs were monitored only in subjects who tested negative for drug allergies in Part Ⅰ.
Incident rate of administration site-related adverse events in Part Ⅱ-B
Outcome measures
| Measure |
ALT-BB4
n=142 Participants
Participants were randomly assigned to receive intradermal administrations of ALT-BB4 or placebo into either the right or left forearm.
|
Placebo
n=72 Participants
Participants were randomly assigned to receive intradermal administrations of ALT-BB4 or placebo into either the right or left forearm.
|
|---|---|---|
|
Injection-site TEAEs (Treatment Emergent Adverse Events)
|
24 events
|
0 events
|
Adverse Events
PartⅠ_ALT-BB4
Serious events: 0 serious events
Other events: 61 other events
Deaths: 0 deaths
PartⅠ_Placebo
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
PartⅡ-A
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
PartⅡ-B_ALT-BB4
Serious events: 0 serious events
Other events: 24 other events
Deaths: 0 deaths
PartⅡ-B_Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
PartⅠ_ALT-BB4
n=244 participants at risk
PartⅠ(Allergy assessment): ALT-BB4 was administered intradermally into the right or left forearm.
|
PartⅠ_Placebo
n=244 participants at risk
PartⅠ(Allergy assessment): Placebo was administered intradermally into the right or left forearm.
|
PartⅡ-A
n=23 participants at risk
PartⅡ-A (PK assessment): ALT-BB4 was administered subcutaneously into the left or right upper arm.
|
PartⅡ-B_ALT-BB4
n=142 participants at risk
PartⅡ-B (Safety assessment): ALT-BB4 was administered subcutaneously into the right or left upper arm.
|
PartⅡ-B_Placebo
n=72 participants at risk
PartⅡ-B (Safety assessment): Placebo was administered subcutaneously into the right or left upper arm.
|
|---|---|---|---|---|---|
|
General disorders
Injection site erythema
|
20.9%
51/244 • up to 28 days
|
0.82%
2/244 • up to 28 days
|
13.0%
3/23 • up to 28 days
|
12.0%
17/142 • up to 28 days
|
0.00%
0/72 • up to 28 days
|
|
General disorders
Injection site telangiectasia
|
3.3%
8/244 • up to 28 days
|
0.00%
0/244 • up to 28 days
|
0.00%
0/23 • up to 28 days
|
4.2%
6/142 • up to 28 days
|
0.00%
0/72 • up to 28 days
|
|
General disorders
Administration site bruise
|
0.00%
0/244 • up to 28 days
|
0.00%
0/244 • up to 28 days
|
0.00%
0/23 • up to 28 days
|
0.70%
1/142 • up to 28 days
|
0.00%
0/72 • up to 28 days
|
|
General disorders
Injection site urticaria
|
0.41%
1/244 • up to 28 days
|
0.41%
1/244 • up to 28 days
|
0.00%
0/23 • up to 28 days
|
0.70%
1/142 • up to 28 days
|
0.00%
0/72 • up to 28 days
|
|
General disorders
Injection site discolouration
|
0.41%
1/244 • up to 28 days
|
0.00%
0/244 • up to 28 days
|
13.0%
3/23 • up to 28 days
|
0.00%
0/142 • up to 28 days
|
0.00%
0/72 • up to 28 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place