Trial Outcomes & Findings for A Study to Evaluate the Safety and Potential Efficacy of LT3001 Drug Product in Subjects With AIS (NCT NCT04091945)

NCT ID: NCT04091945

Last Updated: 2026-01-22

Results Overview

Compare the the percentage of subject having sICH between LT3001 drug product and Placebo.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

24 participants

Primary outcome timeframe

Within 36 hours

Results posted on

2026-01-22

Participant Flow

Participant milestones

Participant milestones
Measure	LT3001 Drug Product LT3001 Drug Product: Active comparator	Placebo Placebo: Placebo comparator
Overall Study STARTED	16	8
Overall Study COMPLETED	14	7
Overall Study NOT COMPLETED	2	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study to Evaluate the Safety and Potential Efficacy of LT3001 Drug Product in Subjects With AIS

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	LT3001 Drug Product n=16 Participants LT3001 Drug Product: Active comparator	Placebo n=8 Participants Placebo: Placebo comparator	Total n=24 Participants Total of all reporting groups
Age, Continuous	62.1 years STANDARD_DEVIATION 12.63 • n=270 Participants	67.6 years STANDARD_DEVIATION 9.24 • n=4 Participants	63.9 years STANDARD_DEVIATION 11.71 • n=9 Participants
Sex: Female, Male Female	4 Participants n=270 Participants	1 Participants n=4 Participants	5 Participants n=9 Participants
Sex: Female, Male Male	12 Participants n=270 Participants	7 Participants n=4 Participants	19 Participants n=9 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=270 Participants	0 Participants n=4 Participants	0 Participants n=9 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	15 Participants n=270 Participants	3 Participants n=4 Participants	18 Participants n=9 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=270 Participants	5 Participants n=4 Participants	6 Participants n=9 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=270 Participants	0 Participants n=4 Participants	0 Participants n=9 Participants
Race (NIH/OMB) Asian	15 Participants n=270 Participants	3 Participants n=4 Participants	18 Participants n=9 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=270 Participants	0 Participants n=4 Participants	0 Participants n=9 Participants
Race (NIH/OMB) Black or African American	0 Participants n=270 Participants	0 Participants n=4 Participants	0 Participants n=9 Participants
Race (NIH/OMB) White	1 Participants n=270 Participants	5 Participants n=4 Participants	6 Participants n=9 Participants
Race (NIH/OMB) More than one race	0 Participants n=270 Participants	0 Participants n=4 Participants	0 Participants n=9 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=270 Participants	0 Participants n=4 Participants	0 Participants n=9 Participants

PRIMARY outcome

Timeframe: Within 36 hours

Compare the the percentage of subject having sICH between LT3001 drug product and Placebo.

Outcome measures

Outcome measures
Measure	LT3001 Drug Product n=16 Participants LT3001 Drug Product: Active comparator	Placebo n=8 Participants Placebo: Placebo comparator
The Percentage of Subject Have Symptomatic Intracranial Hemorrhage (sICH) of a Single Dose LT3001 Drug Product in Subjects With AIS.	0 Participants	0 Participants

Adverse Events

LT3001 Drug Product

Serious events: 4 serious events

Other events: 16 other events

Deaths: 1 deaths

Placebo

Serious events: 2 serious events

Other events: 7 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	LT3001 Drug Product n=16 participants at risk LT3001 Drug Product: Active comparator	Placebo n=8 participants at risk Placebo: Placebo comparator
Infections and infestations COVID-19	0.00% 0/16 • From the time the subject received the IP until the last follow-up visit, approximately 92 days.	12.5% 1/8 • From the time the subject received the IP until the last follow-up visit, approximately 92 days.
Infections and infestations Pneumonia	6.2% 1/16 • From the time the subject received the IP until the last follow-up visit, approximately 92 days.	12.5% 1/8 • From the time the subject received the IP until the last follow-up visit, approximately 92 days.
Infections and infestations Staphylococcal infection	0.00% 0/16 • From the time the subject received the IP until the last follow-up visit, approximately 92 days.	12.5% 1/8 • From the time the subject received the IP until the last follow-up visit, approximately 92 days.
Nervous system disorders Stroke in evolution	12.5% 2/16 • From the time the subject received the IP until the last follow-up visit, approximately 92 days.	0.00% 0/8 • From the time the subject received the IP until the last follow-up visit, approximately 92 days.
Nervous system disorders Cerebral infarction	6.2% 1/16 • From the time the subject received the IP until the last follow-up visit, approximately 92 days.	0.00% 0/8 • From the time the subject received the IP until the last follow-up visit, approximately 92 days.
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	6.2% 1/16 • From the time the subject received the IP until the last follow-up visit, approximately 92 days.	12.5% 1/8 • From the time the subject received the IP until the last follow-up visit, approximately 92 days.
Respiratory, thoracic and mediastinal disorders Respiratory arrest	0.00% 0/16 • From the time the subject received the IP until the last follow-up visit, approximately 92 days.	12.5% 1/8 • From the time the subject received the IP until the last follow-up visit, approximately 92 days.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bronchial neoplasm	6.2% 1/16 • From the time the subject received the IP until the last follow-up visit, approximately 92 days.	0.00% 0/8 • From the time the subject received the IP until the last follow-up visit, approximately 92 days.

Other adverse events

Additional Information

Sabrina Yeh

Lumosa Therapeutics Co., Ltd.

Phone: +886 2 26557918

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60

Measure	LT3001 Drug Product n=16 participants at risk LT3001 Drug Product: Active comparator	Placebo n=8 participants at risk Placebo: Placebo comparator
Investigations C-reactive protein increased	6.2% 1/16 • From the time the subject received the IP until the last follow-up visit, approximately 92 days.	25.0% 2/8 • From the time the subject received the IP until the last follow-up visit, approximately 92 days.
Gastrointestinal disorders Diarrhoea	18.8% 3/16 • From the time the subject received the IP until the last follow-up visit, approximately 92 days.	25.0% 2/8 • From the time the subject received the IP until the last follow-up visit, approximately 92 days.
Gastrointestinal disorders Dyspepsia	12.5% 2/16 • From the time the subject received the IP until the last follow-up visit, approximately 92 days.	0.00% 0/8 • From the time the subject received the IP until the last follow-up visit, approximately 92 days.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	12.5% 2/16 • From the time the subject received the IP until the last follow-up visit, approximately 92 days.	0.00% 0/8 • From the time the subject received the IP until the last follow-up visit, approximately 92 days.
Gastrointestinal disorders Constipation	62.5% 10/16 • From the time the subject received the IP until the last follow-up visit, approximately 92 days.	50.0% 4/8 • From the time the subject received the IP until the last follow-up visit, approximately 92 days.
Nervous system disorders Headache	12.5% 2/16 • From the time the subject received the IP until the last follow-up visit, approximately 92 days.	25.0% 2/8 • From the time the subject received the IP until the last follow-up visit, approximately 92 days.
Metabolism and nutrition disorders Hyperglycaemia	12.5% 2/16 • From the time the subject received the IP until the last follow-up visit, approximately 92 days.	12.5% 1/8 • From the time the subject received the IP until the last follow-up visit, approximately 92 days.
Respiratory, thoracic and mediastinal disorders Cough	18.8% 3/16 • From the time the subject received the IP until the last follow-up visit, approximately 92 days.	0.00% 0/8 • From the time the subject received the IP until the last follow-up visit, approximately 92 days.
Vascular disorders Hypertension	12.5% 2/16 • From the time the subject received the IP until the last follow-up visit, approximately 92 days.	25.0% 2/8 • From the time the subject received the IP until the last follow-up visit, approximately 92 days.
Skin and subcutaneous tissue disorders Erythema	18.8% 3/16 • From the time the subject received the IP until the last follow-up visit, approximately 92 days.	12.5% 1/8 • From the time the subject received the IP until the last follow-up visit, approximately 92 days.
Infections and infestations Pneumonia	12.5% 2/16 • From the time the subject received the IP until the last follow-up visit, approximately 92 days.	25.0% 2/8 • From the time the subject received the IP until the last follow-up visit, approximately 92 days.
Musculoskeletal and connective tissue disorders Arthralgia	12.5% 2/16 • From the time the subject received the IP until the last follow-up visit, approximately 92 days.	12.5% 1/8 • From the time the subject received the IP until the last follow-up visit, approximately 92 days.
Renal and urinary disorders Dysuria	6.2% 1/16 • From the time the subject received the IP until the last follow-up visit, approximately 92 days.	12.5% 1/8 • From the time the subject received the IP until the last follow-up visit, approximately 92 days.
General disorders Oedema peripheral	12.5% 2/16 • From the time the subject received the IP until the last follow-up visit, approximately 92 days.	12.5% 1/8 • From the time the subject received the IP until the last follow-up visit, approximately 92 days.
Cardiac disorders Tachycardia	12.5% 2/16 • From the time the subject received the IP until the last follow-up visit, approximately 92 days.	0.00% 0/8 • From the time the subject received the IP until the last follow-up visit, approximately 92 days.
Gastrointestinal disorders Vomiting	12.5% 2/16 • From the time the subject received the IP until the last follow-up visit, approximately 92 days.	0.00% 0/8 • From the time the subject received the IP until the last follow-up visit, approximately 92 days.
Nervous system disorders Brain oedema	18.8% 3/16 • From the time the subject received the IP until the last follow-up visit, approximately 92 days.	0.00% 0/8 • From the time the subject received the IP until the last follow-up visit, approximately 92 days.
Nervous system disorders Stroke in evolution	12.5% 2/16 • From the time the subject received the IP until the last follow-up visit, approximately 92 days.	12.5% 1/8 • From the time the subject received the IP until the last follow-up visit, approximately 92 days.
Metabolism and nutrition disorders Hypocalcaemia	12.5% 2/16 • From the time the subject received the IP until the last follow-up visit, approximately 92 days.	12.5% 1/8 • From the time the subject received the IP until the last follow-up visit, approximately 92 days.
Metabolism and nutrition disorders Hypokalaemia	18.8% 3/16 • From the time the subject received the IP until the last follow-up visit, approximately 92 days.	0.00% 0/8 • From the time the subject received the IP until the last follow-up visit, approximately 92 days.
Metabolism and nutrition disorders Hyponatraemia	6.2% 1/16 • From the time the subject received the IP until the last follow-up visit, approximately 92 days.	25.0% 2/8 • From the time the subject received the IP until the last follow-up visit, approximately 92 days.
Metabolism and nutrition disorders Hyperlipidaemia	12.5% 2/16 • From the time the subject received the IP until the last follow-up visit, approximately 92 days.	0.00% 0/8 • From the time the subject received the IP until the last follow-up visit, approximately 92 days.
Metabolism and nutrition disorders Hypophosphataemia	12.5% 2/16 • From the time the subject received the IP until the last follow-up visit, approximately 92 days.	0.00% 0/8 • From the time the subject received the IP until the last follow-up visit, approximately 92 days.
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	12.5% 2/16 • From the time the subject received the IP until the last follow-up visit, approximately 92 days.	12.5% 1/8 • From the time the subject received the IP until the last follow-up visit, approximately 92 days.
Respiratory, thoracic and mediastinal disorders Atelectasis	0.00% 0/16 • From the time the subject received the IP until the last follow-up visit, approximately 92 days.	25.0% 2/8 • From the time the subject received the IP until the last follow-up visit, approximately 92 days.
Skin and subcutaneous tissue disorders Rash	18.8% 3/16 • From the time the subject received the IP until the last follow-up visit, approximately 92 days.	12.5% 1/8 • From the time the subject received the IP until the last follow-up visit, approximately 92 days.
Infections and infestations Upper respiratory tract infection	12.5% 2/16 • From the time the subject received the IP until the last follow-up visit, approximately 92 days.	12.5% 1/8 • From the time the subject received the IP until the last follow-up visit, approximately 92 days.
Musculoskeletal and connective tissue disorders Pain in extremity	12.5% 2/16 • From the time the subject received the IP until the last follow-up visit, approximately 92 days.	0.00% 0/8 • From the time the subject received the IP until the last follow-up visit, approximately 92 days.
Renal and urinary disorders Nephrolithiasis	0.00% 0/16 • From the time the subject received the IP until the last follow-up visit, approximately 92 days.	25.0% 2/8 • From the time the subject received the IP until the last follow-up visit, approximately 92 days.