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: 2025-12-30

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 25 participants
• Primary outcome timeframe: Within 36 hours
• Results posted on: 2025-12-30

Participant Flow

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

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=174 Participants	67.6 years STANDARD_DEVIATION 9.24 • n=166 Participants	63.9 years STANDARD_DEVIATION 11.71 • n=167 Participants
Sex: Female, Male Female	4 Participants n=174 Participants	1 Participants n=166 Participants	5 Participants n=167 Participants
Sex: Female, Male Male	12 Participants n=174 Participants	7 Participants n=166 Participants	19 Participants n=167 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=174 Participants	0 Participants n=166 Participants	0 Participants n=167 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	15 Participants n=174 Participants	3 Participants n=166 Participants	18 Participants n=167 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=174 Participants	5 Participants n=166 Participants	6 Participants n=167 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=174 Participants	0 Participants n=166 Participants	0 Participants n=167 Participants
Race (NIH/OMB) Asian	15 Participants n=174 Participants	3 Participants n=166 Participants	18 Participants n=167 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=174 Participants	0 Participants n=166 Participants	0 Participants n=167 Participants
Race (NIH/OMB) Black or African American	0 Participants n=174 Participants	0 Participants n=166 Participants	0 Participants n=167 Participants
Race (NIH/OMB) White	1 Participants n=174 Participants	5 Participants n=166 Participants	6 Participants n=167 Participants
Race (NIH/OMB) More than one race	0 Participants n=174 Participants	0 Participants n=166 Participants	0 Participants n=167 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=174 Participants	0 Participants n=166 Participants	0 Participants n=167 Participants

PRIMARY outcome

Timeframe: Within 36 hours

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

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

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 Pneumonia, COVID-19, Staphylococcal infection	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.
Nervous system disorders Stroke in evolution, Cerebral infarction	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.
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration, Respiratory arrest	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.
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

Measure	LT3001 Drug Product n=16 participants at risk LT3001 Drug Product: Active comparator	Placebo n=8 participants at risk Placebo: Placebo comparator
Renal and urinary disorders Dysuria, Nephrolithiasis	25.0% 4/16 • 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.
General disorders Oedema peripheral	18.8% 3/16 • From the time the subject received the IP until the last follow-up visit, approximately 92 days.	37.5% 3/8 • From the time the subject received the IP until the last follow-up visit, approximately 92 days.
Cardiac disorders Tachycardia	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.
Investigations C-reactive protein increased	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 Constipation, Diarrhoea, Dyspepsia,Upper gastrointestinal haemorrhage, Vomiting	75.0% 12/16 • 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, Brain oedema, Stroke in evolution	50.0% 8/16 • 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.
Metabolism and nutrition disorders Hyperglycaemia, Hypocalcaemia, Hypokalaemia, Hyponatraemia, Hyperlipidaemia, Hypophosphataemia	50.0% 8/16 • From the time the subject received the IP until the last follow-up visit, approximately 92 days.	37.5% 3/8 • From the time the subject received the IP until the last follow-up visit, approximately 92 days.
Respiratory, thoracic and mediastinal disorders Cough, Pneumonia aspiration, Atelectasis	43.8% 7/16 • From the time the subject received the IP until the last follow-up visit, approximately 92 days.	37.5% 3/8 • From the time the subject received the IP until the last follow-up visit, approximately 92 days.
Vascular disorders Hypertension,	43.8% 7/16 • From the time the subject received the IP until the last follow-up visit, approximately 92 days.	37.5% 3/8 • From the time the subject received the IP until the last follow-up visit, approximately 92 days.
Skin and subcutaneous tissue disorders Erythema, Rash	43.8% 7/16 • 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.
Infections and infestations Pneumonia, Upper respiratory tract infection	31.2% 5/16 • From the time the subject received the IP until the last follow-up visit, approximately 92 days.	37.5% 3/8 • From the time the subject received the IP until the last follow-up visit, approximately 92 days.
Musculoskeletal and connective tissue disorders Arthralgia, Pain in extremity	31.2% 5/16 • From the time the subject received the IP until the last follow-up visit, approximately 92 days.	37.5% 3/8 • From the time the subject received the IP until the last follow-up visit, approximately 92 days.

Additional Information

Sabrina Yeh

Lumosa Therapeutics Co., Ltd.

Phone: +886 2 26557918

Email: sabrina_yeh@lumosa.com.tw

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60