Trial Outcomes & Findings for A Study to Evaluate the Safety and Efficacy of Multiple Doses of LT3001 Drug Product in AIS Subjects (NCT NCT05403866)

Last Updated: 2025-12-26

Results Overview

There were no subjects in either treatment group who met the predefined criteria for the primary safety endpoint: the proportion of subjects with TEAEs judged to be probably or definitely related to the IP within 90 days after the first IP administration.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

89 participants

Primary outcome timeframe

within 90 days after the first IP administration

Results posted on

2025-12-26

Participant Flow

Participant milestones

Participant milestones
Measure	LT3001 Drug Product Administered by intravenous infusion LT3001 Drug Product: Administered by intravenous infusion	Placebo Administered by intravenous infusion Placebo: Administered by intravenous infusion
Overall Study STARTED	43	45
Overall Study COMPLETED	37	42
Overall Study NOT COMPLETED	6	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study to Evaluate the Safety and Efficacy of Multiple Doses of LT3001 Drug Product in AIS Subjects

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	LT3001 Drug Product n=43 Participants Administered by intravenous infusion LT3001 Drug Product: Administered by intravenous infusion	Placebo n=45 Participants Administered by intravenous infusion Placebo: Administered by intravenous infusion	Total n=88 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=9 Participants	0 Participants n=6 Participants	0 Participants n=9 Participants
Age, Categorical Between 18 and 65 years	19 Participants n=9 Participants	19 Participants n=6 Participants	38 Participants n=9 Participants
Age, Categorical >=65 years	24 Participants n=9 Participants	26 Participants n=6 Participants	50 Participants n=9 Participants
Age, Continuous	67.3 years STANDARD_DEVIATION 12.28 • n=9 Participants	65.7 years STANDARD_DEVIATION 11.38 • n=6 Participants	66.5 years STANDARD_DEVIATION 11.79 • n=9 Participants
Sex: Female, Male Female	14 Participants n=9 Participants	13 Participants n=6 Participants	27 Participants n=9 Participants
Sex: Female, Male Male	29 Participants n=9 Participants	32 Participants n=6 Participants	61 Participants n=9 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=9 Participants	0 Participants n=6 Participants	0 Participants n=9 Participants
Race (NIH/OMB) Asian	22 Participants n=9 Participants	20 Participants n=6 Participants	42 Participants n=9 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=9 Participants	0 Participants n=6 Participants	0 Participants n=9 Participants
Race (NIH/OMB) Black or African American	3 Participants n=9 Participants	0 Participants n=6 Participants	3 Participants n=9 Participants
Race (NIH/OMB) White	18 Participants n=9 Participants	23 Participants n=6 Participants	41 Participants n=9 Participants
Race (NIH/OMB) More than one race	0 Participants n=9 Participants	0 Participants n=6 Participants	0 Participants n=9 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=9 Participants	2 Participants n=6 Participants	2 Participants n=9 Participants
Weight	74.75 Kg STANDARD_DEVIATION 16.723 • n=9 Participants	74.28 Kg STANDARD_DEVIATION 17.827 • n=6 Participants	74.51 Kg STANDARD_DEVIATION 17.198 • n=9 Participants

PRIMARY outcome

Timeframe: within 90 days after the first IP administration

Population: Safety population

Outcome measures

Outcome measures
Measure	LT3001 Drug Product n=43 Participants Administered by intravenous infusion LT3001 Drug Product: Administered by intravenous infusion	Placebo n=44 Participants Administered by intravenous infusion Placebo: Administered by intravenous infusion
The Proportion of Subjects With Adverse Events (AEs), Judged to be Probably or Definitely Related to the Investigational Product (IP), Within 90 Days After the First IP Administration.	0 Participants	0 Participants

Adverse Events

LT3001 Drug Product

Serious events: 12 serious events

Other events: 37 other events

Deaths: 4 deaths

Placebo

Serious events: 5 serious events

Other events: 33 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	LT3001 Drug Product n=43 participants at risk Administered by intravenous infusion LT3001 Drug Product: Administered by intravenous infusion	Placebo n=44 participants at risk Administered by intravenous infusion Placebo: Administered by intravenous infusion
Nervous system disorders Stroke, Brain oedema, Encephalopathy, Neurological decompensation	14.0% 6/43 • Number of events 6 • From the time the subject received the first IP until the last follow-up visit, approximately 92 days. The same definitions from the clinicaltrials.gov.	9.1% 4/44 • Number of events 4 • From the time the subject received the first IP until the last follow-up visit, approximately 92 days. The same definitions from the clinicaltrials.gov.
Gastrointestinal disorders Colitis ischaemic, Inguinal hernia	4.7% 2/43 • Number of events 2 • From the time the subject received the first IP until the last follow-up visit, approximately 92 days. The same definitions from the clinicaltrials.gov.	0.00% 0/44 • From the time the subject received the first IP until the last follow-up visit, approximately 92 days. The same definitions from the clinicaltrials.gov.
Infections and infestations Pneumonia, Pneumonia aspiration	4.7% 2/43 • Number of events 2 • From the time the subject received the first IP until the last follow-up visit, approximately 92 days. The same definitions from the clinicaltrials.gov.	0.00% 0/44 • From the time the subject received the first IP until the last follow-up visit, approximately 92 days. The same definitions from the clinicaltrials.gov.
Injury, poisoning and procedural complications Fall, Traumatic subarachnoid haemorrhage	4.7% 2/43 • Number of events 2 • From the time the subject received the first IP until the last follow-up visit, approximately 92 days. The same definitions from the clinicaltrials.gov.	0.00% 0/44 • From the time the subject received the first IP until the last follow-up visit, approximately 92 days. The same definitions from the clinicaltrials.gov.
Blood and lymphatic system disorders Leukopenia, Neutropenia	2.3% 1/43 • Number of events 2 • From the time the subject received the first IP until the last follow-up visit, approximately 92 days. The same definitions from the clinicaltrials.gov.	0.00% 0/44 • From the time the subject received the first IP until the last follow-up visit, approximately 92 days. The same definitions from the clinicaltrials.gov.
Cardiac disorders Cardio-respiratory arrest	0.00% 0/43 • From the time the subject received the first IP until the last follow-up visit, approximately 92 days. The same definitions from the clinicaltrials.gov.	2.3% 1/44 • Number of events 1 • From the time the subject received the first IP until the last follow-up visit, approximately 92 days. The same definitions from the clinicaltrials.gov.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma gastric	0.00% 0/43 • From the time the subject received the first IP until the last follow-up visit, approximately 92 days. The same definitions from the clinicaltrials.gov.	2.3% 1/44 • Number of events 1 • From the time the subject received the first IP until the last follow-up visit, approximately 92 days. The same definitions from the clinicaltrials.gov.

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=43 participants at risk Administered by intravenous infusion LT3001 Drug Product: Administered by intravenous infusion	Placebo n=44 participants at risk Administered by intravenous infusion Placebo: Administered by intravenous infusion
Gastrointestinal disorders Constipation, Diarrhoea	39.5% 17/43 • Number of events 32 • From the time the subject received the first IP until the last follow-up visit, approximately 92 days. The same definitions from the clinicaltrials.gov.	38.6% 17/44 • Number of events 24 • From the time the subject received the first IP until the last follow-up visit, approximately 92 days. The same definitions from the clinicaltrials.gov.
Investigations Investigations	2.3% 1/43 • Number of events 1 • From the time the subject received the first IP until the last follow-up visit, approximately 92 days. The same definitions from the clinicaltrials.gov.	13.6% 6/44 • Number of events 8 • From the time the subject received the first IP until the last follow-up visit, approximately 92 days. The same definitions from the clinicaltrials.gov.
Vascular disorders Hypertension	4.7% 2/43 • Number of events 2 • From the time the subject received the first IP until the last follow-up visit, approximately 92 days. The same definitions from the clinicaltrials.gov.	11.4% 5/44 • Number of events 5 • From the time the subject received the first IP until the last follow-up visit, approximately 92 days. The same definitions from the clinicaltrials.gov.
Infections and infestations UTI, Pneumonia, Pneumonia aspiration, COVID-19, Conjunctivitis	41.9% 18/43 • Number of events 27 • From the time the subject received the first IP until the last follow-up visit, approximately 92 days. The same definitions from the clinicaltrials.gov.	25.0% 11/44 • Number of events 17 • From the time the subject received the first IP until the last follow-up visit, approximately 92 days. The same definitions from the clinicaltrials.gov.
Metabolism and nutrition disorders Hyperlipidaemia, Hypokalaemia	37.2% 16/43 • Number of events 26 • From the time the subject received the first IP until the last follow-up visit, approximately 92 days. The same definitions from the clinicaltrials.gov.	27.3% 12/44 • Number of events 17 • From the time the subject received the first IP until the last follow-up visit, approximately 92 days. The same definitions from the clinicaltrials.gov.
Nervous system disorders Headache, Stroke, Brain oedema	30.2% 13/43 • Number of events 24 • From the time the subject received the first IP until the last follow-up visit, approximately 92 days. The same definitions from the clinicaltrials.gov.	20.5% 9/44 • Number of events 13 • From the time the subject received the first IP until the last follow-up visit, approximately 92 days. The same definitions from the clinicaltrials.gov.
Psychiatric disorders Insomnia	20.9% 9/43 • Number of events 9 • From the time the subject received the first IP until the last follow-up visit, approximately 92 days. The same definitions from the clinicaltrials.gov.	22.7% 10/44 • Number of events 13 • From the time the subject received the first IP until the last follow-up visit, approximately 92 days. The same definitions from the clinicaltrials.gov.
Musculoskeletal and connective tissue disorders Arthralgia, Muscle spasms	20.9% 9/43 • Number of events 11 • From the time the subject received the first IP until the last follow-up visit, approximately 92 days. The same definitions from the clinicaltrials.gov.	15.9% 7/44 • Number of events 12 • From the time the subject received the first IP until the last follow-up visit, approximately 92 days. The same definitions from the clinicaltrials.gov.
Respiratory, thoracic and mediastinal disorders Cough	20.9% 9/43 • Number of events 11 • From the time the subject received the first IP until the last follow-up visit, approximately 92 days. The same definitions from the clinicaltrials.gov.	15.9% 7/44 • Number of events 10 • From the time the subject received the first IP until the last follow-up visit, approximately 92 days. The same definitions from the clinicaltrials.gov.
General disorders Pyrexia	14.0% 6/43 • Number of events 8 • From the time the subject received the first IP until the last follow-up visit, approximately 92 days. The same definitions from the clinicaltrials.gov.	9.1% 4/44 • Number of events 4 • From the time the subject received the first IP until the last follow-up visit, approximately 92 days. The same definitions from the clinicaltrials.gov.
Renal and urinary disorders Renal and urinary disorders	11.6% 5/43 • Number of events 7 • From the time the subject received the first IP until the last follow-up visit, approximately 92 days. The same definitions from the clinicaltrials.gov.	11.4% 5/44 • Number of events 6 • From the time the subject received the first IP until the last follow-up visit, approximately 92 days. The same definitions from the clinicaltrials.gov.
Cardiac disorders Cardiac disorders	9.3% 4/43 • Number of events 4 • From the time the subject received the first IP until the last follow-up visit, approximately 92 days. The same definitions from the clinicaltrials.gov.	13.6% 6/44 • Number of events 6 • From the time the subject received the first IP until the last follow-up visit, approximately 92 days. The same definitions from the clinicaltrials.gov.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders	16.3% 7/43 • Number of events 8 • From the time the subject received the first IP until the last follow-up visit, approximately 92 days. The same definitions from the clinicaltrials.gov.	6.8% 3/44 • Number of events 3 • From the time the subject received the first IP until the last follow-up visit, approximately 92 days. The same definitions from the clinicaltrials.gov.
Injury, poisoning and procedural complications Injury, poisoning and procedural complications	14.0% 6/43 • Number of events 8 • From the time the subject received the first IP until the last follow-up visit, approximately 92 days. The same definitions from the clinicaltrials.gov.	6.8% 3/44 • Number of events 3 • From the time the subject received the first IP until the last follow-up visit, approximately 92 days. The same definitions from the clinicaltrials.gov.
Blood and lymphatic system disorders Blood and lymphatic system disorders	7.0% 3/43 • Number of events 4 • From the time the subject received the first IP until the last follow-up visit, approximately 92 days. The same definitions from the clinicaltrials.gov.	11.4% 5/44 • Number of events 5 • From the time the subject received the first IP until the last follow-up visit, approximately 92 days. The same definitions from the clinicaltrials.gov.