Trial Outcomes & Findings for A Phase I Study to Evaluate LSALT Peptide (NCT NCT03772678)
NCT ID: NCT03772678
Last Updated: 2024-11-29
Results Overview
To determine the safety and tolerability of 3 single and multiple ascending doses of LSALT peptide (1.0mg, 2.5mg, 5.0mg) in healthy participants.
Recruitment status
COMPLETED
Study phase
EARLY_PHASE1
Target enrollment
52 participants
Primary outcome timeframe
Within 21 days
Results posted on
2024-11-29
Participant Flow
Participant milestones
| Measure |
LSALT Peptide - 0.01mg
LSALT peptide (1mg/mL in 0.9% saline) single dose intravenously.
Escalation to 0.1mg dose in next cohort if no adverse effects are seen after 3 days.
LSALT peptide: novel 16 amino acid peptide
|
LSALT Peptide - 0.1mg
LSALT peptide (1mg/mL in 0.9% saline) single dose intravenously.
Escalation to 0.3mg dose in next cohort if no adverse effects are seen after 3 days.
LSALT peptide: novel 16 amino acid peptide
|
LSALT Peptide - 0.3mg
LSALT peptide (1mg/mL in 0.9% saline) single dose intravenously.
Escalation to 0.5mg dose in next cohort if no adverse effects are seen after 3 days.
LSALT peptide: novel 16 amino acid peptide
|
LSALT Peptide - 0.5mg
LSALT peptide (1mg/mL in 0.9% saline) single dose intravenously.
Escalation to 1.0mg dose in next cohort if no adverse effects are seen after 10-14 days.
LSALT peptide: novel 16 amino acid peptide
|
LSALT Peptide - 1.0mg
LSALT peptide (1mg/mL in 0.9% saline) single dose - 1.0mg intravenously over 2h.
Escalation to next dose (2.5mg) in next cohort if no adverse effects are seen.
LSALT peptide: novel 16 amino acid peptide
|
LSALT Peptide - 2.5mg
LSALT peptide (1mg/mL in 0.9% saline) single dose - 2.5mg intravenously over 2h.
Escalation to next dose (5.0mg) in next cohort if no adverse effects are seen.
LSALT peptide: novel 16 amino acid peptide
|
LSALT Peptide - 5.0mg
LSALT peptide (1mg/mL in 0.9% saline) single dose - 5.0mg intravenously over 2h.
Escalation to multiple ascending dose cohort if no adverse effects are seen.
LSALT peptide: novel 16 amino acid peptide
|
Placebo - Single Dose
0.9% saline as placebo for single dose cohorts (1.0mg, 2.5mg, 5.0mg)
|
LSALT Peptide - 1.0mg, Multiple Ascending Dose
LSALT peptide (1mg/mL in 0.9% saline) single dose (1.0mg) per day intravenously over 2h.
LSALT will be administered intravenously once daily for 3 days.
LSALT peptide: novel 16 amino acid peptide
|
LSALT Peptide - 2.5mg, Multiple Ascending Dose
LSALT peptide (1mg/mL in 0.9% saline) single dose (2.5mg) per day intravenously over 2h.
LSALT will be administered intravenously once daily for 3 days.
LSALT peptide: novel 16 amino acid peptide
|
LSALT Peptide - 5.0mg, Multiple Ascending Dose
LSALT peptide (1mg/mL in 0.9% saline) single dose (5.0mg) per day intravenously over 2h.
LSALT will be administered intravenously once daily for 3 days.
LSALT peptide: novel 16 amino acid peptide
|
Placebo - Multiple Ascending Dose
0.9% saline as placebo for multiple ascending dose cohorts (1.0mg, 2.5mg, 5.0mg)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
1
|
1
|
1
|
1
|
6
|
6
|
6
|
6
|
6
|
6
|
6
|
6
|
|
Overall Study
COMPLETED
|
1
|
1
|
1
|
1
|
5
|
5
|
6
|
5
|
6
|
6
|
6
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
1
|
1
|
0
|
1
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Phase I Study to Evaluate LSALT Peptide
Baseline characteristics by cohort
| Measure |
LSALT Peptide - 0.01mg
n=1 Participants
LSALT peptide (1mg/mL in 0.9% saline) single dose intravenously. Escalation to 0.1mg dose in next cohort if no adverse effects are seen after 3 days.
LSALT peptide: novel 16 amino acid peptide
|
LSALT Peptide - 0.1mg
n=1 Participants
LSALT peptide (1mg/mL in 0.9% saline) single dose intravenously. Escalation to 0.3mg dose in next cohort if no adverse effects are seen after 3 days.
LSALT peptide: novel 16 amino acid peptide
|
LSALT Peptide - 0.3mg
n=1 Participants
LSALT peptide (1mg/mL in 0.9% saline) single dose intravenously. Escalation to 0.5mg dose in next cohort if no adverse effects are seen after 3 days.
LSALT peptide: novel 16 amino acid peptide
|
LSALT Peptide - 0.5mg
n=1 Participants
LSALT peptide (1mg/mL in 0.9% saline) single dose intravenously. Escalation to 1.0mg dose in next cohort if no adverse effects are seen after 10-14 days.
LSALT peptide: novel 16 amino acid peptide
|
LSALT Peptide - 1.0mg
n=6 Participants
LSALT peptide (1mg/mL in 0.9% saline) single dose - 1.0mg intravenously over 2h.
Escalation to next dose (2.5mg) in next cohort if no adverse effects are seen. LSALT peptide: novel 16 amino acid peptide
|
LSALT Peptide - 2.5mg
n=6 Participants
LSALT peptide (1mg/mL in 0.9% saline) single dose - 2.5mg intravenously over 2h.
Escalation to next dose (5.0mg) in next cohort if no adverse effects are seen. LSALT peptide: novel 16 amino acid peptide
|
LSALT Peptide - 5.0mg
n=6 Participants
LSALT peptide (1mg/mL in 0.9% saline) single dose - 5.0mg intravenously over 2h.
Escalation to multiple ascending dose cohort if no adverse effects are seen. LSALT peptide: novel 16 amino acid peptide
|
Placebo - Single Dose
n=6 Participants
0.9% saline as placebo for single dose cohorts (1.0mg, 2.5mg, 5.0mg)
|
LSALT Peptide - 1.0mg, Multiple Ascending Dose
n=6 Participants
LSALT peptide (1mg/mL in 0.9% saline) single dose (1.0mg) per day intravenously over 2h.
LSALT will be administered intravenously once daily for 3 days. LSALT peptide: novel 16 amino acid peptide
|
LSALT Peptide - 2.5mg, Multiple Ascending Dose
n=6 Participants
LSALT peptide (1mg/mL in 0.9% saline) single dose (2.5mg) per day intravenously over 2h.
LSALT will be administered intravenously once daily for 3 days. LSALT peptide: novel 16 amino acid peptide
|
LSALT Peptide - 5.0mg, Multiple Ascending Dose
n=6 Participants
LSALT peptide (1mg/mL in 0.9% saline) single dose (5.0mg) per day intravenously over 2h.
LSALT will be administered intravenously once daily for 3 days. LSALT peptide: novel 16 amino acid peptide
|
Placebo - Multiple Ascending Dose
n=6 Participants
0.9% saline as placebo for multiple ascending dose cohorts
|
Total
n=52 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
6 Participants
n=8 Participants
|
6 Participants
n=24 Participants
|
6 Participants
n=42 Participants
|
6 Participants
n=42 Participants
|
6 Participants
n=42 Participants
|
6 Participants
n=42 Participants
|
52 Participants
n=36 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
3 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
21 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
3 Participants
n=24 Participants
|
5 Participants
n=42 Participants
|
4 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
4 Participants
n=42 Participants
|
31 Participants
n=36 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
3 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
17 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=36 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
5 Participants
n=24 Participants
|
3 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
4 Participants
n=42 Participants
|
4 Participants
n=42 Participants
|
33 Participants
n=36 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=36 Participants
|
PRIMARY outcome
Timeframe: Within 21 daysPopulation: The Safety Population was comprised of all randomised subjects who received any amount of study drug in the single ascending dose and multiple ascending dose cohorts and were based on the actual treatment received, if this differs from that to which the subject was randomised. The Safety Population was used for the summaries of all safety tolerability.
To determine the safety and tolerability of 3 single and multiple ascending doses of LSALT peptide (1.0mg, 2.5mg, 5.0mg) in healthy participants.
Outcome measures
| Measure |
LSALT Peptide - 0.01mg
LSALT peptide (1mg/mL in 0.9% saline) single dose intravenously. Escalation to 0.1mg dose in next cohort if no adverse effects are seen after 3 days.
LSALT peptide: novel 16 amino acid peptide
|
LSALT Peptide - 0.1mg
LSALT peptide (1mg/mL in 0.9% saline) single dose intravenously. Escalation to 0.3mg dose in next cohort if no adverse effects are seen after 3 days.
LSALT peptide: novel 16 amino acid peptide
|
LSALT Peptide - 0.3mg
LSALT peptide (1mg/mL in 0.9% saline) single dose intravenously. Escalation to 0.5mg dose in next cohort if no adverse effects are seen after 3 days.
LSALT peptide: novel 16 amino acid peptide
|
LSALT Peptide - 0.5mg
LSALT peptide (1mg/mL in 0.9% saline) single dose intravenously. Escalation to 1.0mg dose in next cohort if no adverse effects are seen after 10-14 days.
LSALT peptide: novel 16 amino acid peptide
|
LSALT Peptide - 1.0mg
n=6 Participants
LSALT peptide (1mg/mL in 0.9% saline) single dose - 1.0mg intravenously over 2h.
Escalation to next dose (2.5mg) in next cohort if no adverse effects are seen. LSALT peptide: novel 16 amino acid peptide
|
LSALT Peptide - 2.5mg
n=6 Participants
LSALT peptide (1mg/mL in 0.9% saline) single dose - 2.5mg intravenously over 2h.
Escalation to next dose (5.0mg) in next cohort if no adverse effects are seen. LSALT peptide: novel 16 amino acid peptide
|
LSALT Peptide - 5.0mg
n=6 Participants
LSALT peptide (1mg/mL in 0.9% saline) single dose - 5.0mg intravenously over 2h.
Escalation to multiple ascending dose cohort if no adverse effects are seen. LSALT peptide: novel 16 amino acid peptide
|
Placebo - Single Dose
n=6 Participants
0.9% saline as placebo for single dose cohorts (1.0mg, 2.5mg, 5.0mg)
|
LSALT Peptide - 1.0mg, Multiple Ascending Dose
n=6 Participants
LSALT peptide (1mg/mL in 0.9% saline) single dose (1.0mg) per day intravenously over 2h.
LSALT will be administered intravenously once daily for 3 days. LSALT peptide: novel 16 amino acid peptide
|
LSALT Peptide - 2.5mg, Multiple Ascending Dose
n=6 Participants
LSALT peptide (1mg/mL in 0.9% saline) single dose (2.5mg) per day intravenously over 2h.
LSALT will be administered intravenously once daily for 3 days. LSALT peptide: novel 16 amino acid peptide
|
LSALT Peptide - 5.0mg, Multiple Ascending Dose
n=6 Participants
LSALT peptide (1mg/mL in 0.9% saline) single dose (5.0mg) per day intravenously over 2h.
LSALT will be administered intravenously once daily for 3 days. LSALT peptide: novel 16 amino acid peptide
|
Placebo - Multiple Ascending Dose
n=6 Participants
0.9% saline as placebo for multiple ascending dose cohorts (1.0mg, 2.5mg, 5.0mg)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Safety Evaluation
At least One TEAE
|
—
|
—
|
—
|
—
|
3 participants
|
1 participants
|
6 participants
|
2 participants
|
5 participants
|
4 participants
|
2 participants
|
5 participants
|
|
Safety Evaluation
At least One Severe or Life-threatening TEAE
|
—
|
—
|
—
|
—
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Safety Evaluation
At least One Study Drug-related TEAE
|
—
|
—
|
—
|
—
|
0 participants
|
0 participants
|
2 participants
|
1 participants
|
3 participants
|
1 participants
|
1 participants
|
1 participants
|
|
Safety Evaluation
At least One Serious TEAE
|
—
|
—
|
—
|
—
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Safety Evaluation
At least One Serious Study Drug-related TEAE
|
—
|
—
|
—
|
—
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Safety Evaluation
Discontinuation due to TEAE
|
—
|
—
|
—
|
—
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Safety Evaluation
Death
|
—
|
—
|
—
|
—
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Within 21 daysPopulation: The PK Concentration Population was comprised of all subjects who received any amount of LSALT, who had at least 1 quantifiable PK concentration and was based on the actual treatment received, if this differs from that to which the subject was randomized. Subjects who received only placebo was excluded from the PK Concentration Population. The PK Concentration Population was used for the summaries of all PK concentration data.
To evaluate the PK and pharmacodynamics (PD) of LSALT peptide in healthy participants.
Outcome measures
| Measure |
LSALT Peptide - 0.01mg
n=6 Participants
LSALT peptide (1mg/mL in 0.9% saline) single dose intravenously. Escalation to 0.1mg dose in next cohort if no adverse effects are seen after 3 days.
LSALT peptide: novel 16 amino acid peptide
|
LSALT Peptide - 0.1mg
n=6 Participants
LSALT peptide (1mg/mL in 0.9% saline) single dose intravenously. Escalation to 0.3mg dose in next cohort if no adverse effects are seen after 3 days.
LSALT peptide: novel 16 amino acid peptide
|
LSALT Peptide - 0.3mg
LSALT peptide (1mg/mL in 0.9% saline) single dose intravenously. Escalation to 0.5mg dose in next cohort if no adverse effects are seen after 3 days.
LSALT peptide: novel 16 amino acid peptide
|
LSALT Peptide - 0.5mg
LSALT peptide (1mg/mL in 0.9% saline) single dose intravenously. Escalation to 1.0mg dose in next cohort if no adverse effects are seen after 10-14 days.
LSALT peptide: novel 16 amino acid peptide
|
LSALT Peptide - 1.0mg
LSALT peptide (1mg/mL in 0.9% saline) single dose - 1.0mg intravenously over 2h.
Escalation to next dose (2.5mg) in next cohort if no adverse effects are seen. LSALT peptide: novel 16 amino acid peptide
|
LSALT Peptide - 2.5mg
LSALT peptide (1mg/mL in 0.9% saline) single dose - 2.5mg intravenously over 2h.
Escalation to next dose (5.0mg) in next cohort if no adverse effects are seen. LSALT peptide: novel 16 amino acid peptide
|
LSALT Peptide - 5.0mg
LSALT peptide (1mg/mL in 0.9% saline) single dose - 5.0mg intravenously over 2h.
Escalation to multiple ascending dose cohort if no adverse effects are seen. LSALT peptide: novel 16 amino acid peptide
|
Placebo - Single Dose
0.9% saline as placebo for single dose cohorts (1.0mg, 2.5mg, 5.0mg)
|
LSALT Peptide - 1.0mg, Multiple Ascending Dose
LSALT peptide (1mg/mL in 0.9% saline) single dose (1.0mg) per day intravenously over 2h.
LSALT will be administered intravenously once daily for 3 days. LSALT peptide: novel 16 amino acid peptide
|
LSALT Peptide - 2.5mg, Multiple Ascending Dose
LSALT peptide (1mg/mL in 0.9% saline) single dose (2.5mg) per day intravenously over 2h.
LSALT will be administered intravenously once daily for 3 days. LSALT peptide: novel 16 amino acid peptide
|
LSALT Peptide - 5.0mg, Multiple Ascending Dose
LSALT peptide (1mg/mL in 0.9% saline) single dose (5.0mg) per day intravenously over 2h.
LSALT will be administered intravenously once daily for 3 days. LSALT peptide: novel 16 amino acid peptide
|
Placebo - Multiple Ascending Dose
0.9% saline as placebo for multiple ascending dose cohorts (1.0mg, 2.5mg, 5.0mg)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetic Evaluation
Tmax (h)
|
1.33 hours
Standard Deviation 0.6
|
1.17 hours
Standard Deviation 0.516
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Pharmacokinetic Evaluation
T1/2 (h)
|
0.41 hours
Standard Deviation 0.147
|
0.21 hours
Standard Deviation 0.075
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
LSALT Peptide - 0.01mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
LSALT Peptide - 0.1mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
LSALT Peptide - 0.3mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
LSALT Peptide - 0.5mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
LSALT Peptide - 1.0mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
LSALT Peptide - 2.5mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
LSALT Peptide - 5.0mg
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Placebo - Single Dose
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
LSALT Peptide - 1.0mg, Multiple Ascending Dose
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
LSALT Peptide - 2.5mg, Multiple Ascending Dose
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
LSALT Peptide - 5.0mg, Multiple Ascending Dose
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Placebo - Multiple Ascending Dose
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
LSALT Peptide - 0.01mg
n=1 participants at risk
LSALT peptide (1mg/mL in 0.9% saline) single dose intravenously. Escalation to 0.1mg dose in next cohort if no adverse effects are seen after 3 days.
LSALT peptide: novel 16 amino acid peptide
|
LSALT Peptide - 0.1mg
n=1 participants at risk
LSALT peptide (1mg/mL in 0.9% saline) single dose intravenously. Escalation to 0.3mg dose in next cohort if no adverse effects are seen after 3 days.
LSALT peptide: novel 16 amino acid peptide
|
LSALT Peptide - 0.3mg
n=1 participants at risk
LSALT peptide (1mg/mL in 0.9% saline) single dose intravenously. Escalation to 0.5mg dose in next cohort if no adverse effects are seen after 3 days.
LSALT peptide: novel 16 amino acid peptide
|
LSALT Peptide - 0.5mg
n=1 participants at risk
LSALT peptide (1mg/mL in 0.9% saline) single dose intravenously. Escalation to 1.0mg dose in next cohort if no adverse effects are seen after 10-14 days.
LSALT peptide: novel 16 amino acid peptide
|
LSALT Peptide - 1.0mg
n=6 participants at risk
LSALT peptide (1mg/mL in 0.9% saline) single dose - 1.0mg intravenously over 2h.
Escalation to next dose (2.5mg) in next cohort if no adverse effects are seen. LSALT peptide: novel 16 amino acid peptide
|
LSALT Peptide - 2.5mg
n=6 participants at risk
LSALT peptide (1mg/mL in 0.9% saline) single dose - 2.5mg intravenously over 2h.
Escalation to next dose (5.0mg) in next cohort if no adverse effects are seen. LSALT peptide: novel 16 amino acid peptide
|
LSALT Peptide - 5.0mg
n=6 participants at risk
LSALT peptide (1mg/mL in 0.9% saline) single dose - 5.0mg intravenously over 2h.
Escalation to multiple ascending dose cohort if no adverse effects are seen. LSALT peptide: novel 16 amino acid peptide
|
Placebo - Single Dose
n=6 participants at risk
0.9% saline as placebo for single dose cohorts (1.0mg, 2.5mg, 5.0mg)
|
LSALT Peptide - 1.0mg, Multiple Ascending Dose
n=6 participants at risk
LSALT peptide (1mg/mL in 0.9% saline) single dose (1.0mg) per day intravenously over 2h.
LSALT will be administered intravenously once daily for 3 days. LSALT peptide: novel 16 amino acid peptide
|
LSALT Peptide - 2.5mg, Multiple Ascending Dose
n=6 participants at risk
LSALT peptide (1mg/mL in 0.9% saline) single dose (2.5mg) per day intravenously over 2h.
LSALT will be administered intravenously once daily for 3 days. LSALT peptide: novel 16 amino acid peptide
|
LSALT Peptide - 5.0mg, Multiple Ascending Dose
n=6 participants at risk
LSALT peptide (1mg/mL in 0.9% saline) single dose (5.0mg) per day intravenously over 2h.
LSALT will be administered intravenously once daily for 3 days. LSALT peptide: novel 16 amino acid peptide
|
Placebo - Multiple Ascending Dose
n=6 participants at risk
0.9% saline as placebo for multiple ascending dose cohorts (1.0mg, 2.5mg, 5.0mg)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Injury, poisoning and procedural complications
General Disorders and Administration Site Conditions
|
0.00%
0/1 • For Low Dose cohort - study subjects were monitored for 3 days For SAD cohort - study subjects were monitored for 7 days For MAD cohort - study subjects were monitored for 21 days
|
0.00%
0/1 • For Low Dose cohort - study subjects were monitored for 3 days For SAD cohort - study subjects were monitored for 7 days For MAD cohort - study subjects were monitored for 21 days
|
0.00%
0/1 • For Low Dose cohort - study subjects were monitored for 3 days For SAD cohort - study subjects were monitored for 7 days For MAD cohort - study subjects were monitored for 21 days
|
0.00%
0/1 • For Low Dose cohort - study subjects were monitored for 3 days For SAD cohort - study subjects were monitored for 7 days For MAD cohort - study subjects were monitored for 21 days
|
50.0%
3/6 • For Low Dose cohort - study subjects were monitored for 3 days For SAD cohort - study subjects were monitored for 7 days For MAD cohort - study subjects were monitored for 21 days
|
16.7%
1/6 • For Low Dose cohort - study subjects were monitored for 3 days For SAD cohort - study subjects were monitored for 7 days For MAD cohort - study subjects were monitored for 21 days
|
100.0%
6/6 • For Low Dose cohort - study subjects were monitored for 3 days For SAD cohort - study subjects were monitored for 7 days For MAD cohort - study subjects were monitored for 21 days
|
33.3%
2/6 • For Low Dose cohort - study subjects were monitored for 3 days For SAD cohort - study subjects were monitored for 7 days For MAD cohort - study subjects were monitored for 21 days
|
50.0%
3/6 • For Low Dose cohort - study subjects were monitored for 3 days For SAD cohort - study subjects were monitored for 7 days For MAD cohort - study subjects were monitored for 21 days
|
50.0%
3/6 • For Low Dose cohort - study subjects were monitored for 3 days For SAD cohort - study subjects were monitored for 7 days For MAD cohort - study subjects were monitored for 21 days
|
0.00%
0/6 • For Low Dose cohort - study subjects were monitored for 3 days For SAD cohort - study subjects were monitored for 7 days For MAD cohort - study subjects were monitored for 21 days
|
0.00%
0/6 • For Low Dose cohort - study subjects were monitored for 3 days For SAD cohort - study subjects were monitored for 7 days For MAD cohort - study subjects were monitored for 21 days
|
|
Infections and infestations
Infections and Infestations
|
0.00%
0/1 • For Low Dose cohort - study subjects were monitored for 3 days For SAD cohort - study subjects were monitored for 7 days For MAD cohort - study subjects were monitored for 21 days
|
0.00%
0/1 • For Low Dose cohort - study subjects were monitored for 3 days For SAD cohort - study subjects were monitored for 7 days For MAD cohort - study subjects were monitored for 21 days
|
0.00%
0/1 • For Low Dose cohort - study subjects were monitored for 3 days For SAD cohort - study subjects were monitored for 7 days For MAD cohort - study subjects were monitored for 21 days
|
0.00%
0/1 • For Low Dose cohort - study subjects were monitored for 3 days For SAD cohort - study subjects were monitored for 7 days For MAD cohort - study subjects were monitored for 21 days
|
16.7%
1/6 • For Low Dose cohort - study subjects were monitored for 3 days For SAD cohort - study subjects were monitored for 7 days For MAD cohort - study subjects were monitored for 21 days
|
0.00%
0/6 • For Low Dose cohort - study subjects were monitored for 3 days For SAD cohort - study subjects were monitored for 7 days For MAD cohort - study subjects were monitored for 21 days
|
33.3%
2/6 • For Low Dose cohort - study subjects were monitored for 3 days For SAD cohort - study subjects were monitored for 7 days For MAD cohort - study subjects were monitored for 21 days
|
0.00%
0/6 • For Low Dose cohort - study subjects were monitored for 3 days For SAD cohort - study subjects were monitored for 7 days For MAD cohort - study subjects were monitored for 21 days
|
0.00%
0/6 • For Low Dose cohort - study subjects were monitored for 3 days For SAD cohort - study subjects were monitored for 7 days For MAD cohort - study subjects were monitored for 21 days
|
0.00%
0/6 • For Low Dose cohort - study subjects were monitored for 3 days For SAD cohort - study subjects were monitored for 7 days For MAD cohort - study subjects were monitored for 21 days
|
0.00%
0/6 • For Low Dose cohort - study subjects were monitored for 3 days For SAD cohort - study subjects were monitored for 7 days For MAD cohort - study subjects were monitored for 21 days
|
33.3%
2/6 • For Low Dose cohort - study subjects were monitored for 3 days For SAD cohort - study subjects were monitored for 7 days For MAD cohort - study subjects were monitored for 21 days
|
|
Nervous system disorders
Nervous System Disorders
|
0.00%
0/1 • For Low Dose cohort - study subjects were monitored for 3 days For SAD cohort - study subjects were monitored for 7 days For MAD cohort - study subjects were monitored for 21 days
|
0.00%
0/1 • For Low Dose cohort - study subjects were monitored for 3 days For SAD cohort - study subjects were monitored for 7 days For MAD cohort - study subjects were monitored for 21 days
|
0.00%
0/1 • For Low Dose cohort - study subjects were monitored for 3 days For SAD cohort - study subjects were monitored for 7 days For MAD cohort - study subjects were monitored for 21 days
|
0.00%
0/1 • For Low Dose cohort - study subjects were monitored for 3 days For SAD cohort - study subjects were monitored for 7 days For MAD cohort - study subjects were monitored for 21 days
|
0.00%
0/6 • For Low Dose cohort - study subjects were monitored for 3 days For SAD cohort - study subjects were monitored for 7 days For MAD cohort - study subjects were monitored for 21 days
|
0.00%
0/6 • For Low Dose cohort - study subjects were monitored for 3 days For SAD cohort - study subjects were monitored for 7 days For MAD cohort - study subjects were monitored for 21 days
|
33.3%
2/6 • For Low Dose cohort - study subjects were monitored for 3 days For SAD cohort - study subjects were monitored for 7 days For MAD cohort - study subjects were monitored for 21 days
|
0.00%
0/6 • For Low Dose cohort - study subjects were monitored for 3 days For SAD cohort - study subjects were monitored for 7 days For MAD cohort - study subjects were monitored for 21 days
|
50.0%
3/6 • For Low Dose cohort - study subjects were monitored for 3 days For SAD cohort - study subjects were monitored for 7 days For MAD cohort - study subjects were monitored for 21 days
|
50.0%
3/6 • For Low Dose cohort - study subjects were monitored for 3 days For SAD cohort - study subjects were monitored for 7 days For MAD cohort - study subjects were monitored for 21 days
|
0.00%
0/6 • For Low Dose cohort - study subjects were monitored for 3 days For SAD cohort - study subjects were monitored for 7 days For MAD cohort - study subjects were monitored for 21 days
|
0.00%
0/6 • For Low Dose cohort - study subjects were monitored for 3 days For SAD cohort - study subjects were monitored for 7 days For MAD cohort - study subjects were monitored for 21 days
|
|
Gastrointestinal disorders
Gastrointestinal Disorders
|
0.00%
0/1 • For Low Dose cohort - study subjects were monitored for 3 days For SAD cohort - study subjects were monitored for 7 days For MAD cohort - study subjects were monitored for 21 days
|
0.00%
0/1 • For Low Dose cohort - study subjects were monitored for 3 days For SAD cohort - study subjects were monitored for 7 days For MAD cohort - study subjects were monitored for 21 days
|
0.00%
0/1 • For Low Dose cohort - study subjects were monitored for 3 days For SAD cohort - study subjects were monitored for 7 days For MAD cohort - study subjects were monitored for 21 days
|
0.00%
0/1 • For Low Dose cohort - study subjects were monitored for 3 days For SAD cohort - study subjects were monitored for 7 days For MAD cohort - study subjects were monitored for 21 days
|
0.00%
0/6 • For Low Dose cohort - study subjects were monitored for 3 days For SAD cohort - study subjects were monitored for 7 days For MAD cohort - study subjects were monitored for 21 days
|
16.7%
1/6 • For Low Dose cohort - study subjects were monitored for 3 days For SAD cohort - study subjects were monitored for 7 days For MAD cohort - study subjects were monitored for 21 days
|
0.00%
0/6 • For Low Dose cohort - study subjects were monitored for 3 days For SAD cohort - study subjects were monitored for 7 days For MAD cohort - study subjects were monitored for 21 days
|
0.00%
0/6 • For Low Dose cohort - study subjects were monitored for 3 days For SAD cohort - study subjects were monitored for 7 days For MAD cohort - study subjects were monitored for 21 days
|
0.00%
0/6 • For Low Dose cohort - study subjects were monitored for 3 days For SAD cohort - study subjects were monitored for 7 days For MAD cohort - study subjects were monitored for 21 days
|
0.00%
0/6 • For Low Dose cohort - study subjects were monitored for 3 days For SAD cohort - study subjects were monitored for 7 days For MAD cohort - study subjects were monitored for 21 days
|
33.3%
2/6 • For Low Dose cohort - study subjects were monitored for 3 days For SAD cohort - study subjects were monitored for 7 days For MAD cohort - study subjects were monitored for 21 days
|
16.7%
1/6 • For Low Dose cohort - study subjects were monitored for 3 days For SAD cohort - study subjects were monitored for 7 days For MAD cohort - study subjects were monitored for 21 days
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, Thoracic, and Mediastinal Disorders
|
0.00%
0/1 • For Low Dose cohort - study subjects were monitored for 3 days For SAD cohort - study subjects were monitored for 7 days For MAD cohort - study subjects were monitored for 21 days
|
0.00%
0/1 • For Low Dose cohort - study subjects were monitored for 3 days For SAD cohort - study subjects were monitored for 7 days For MAD cohort - study subjects were monitored for 21 days
|
0.00%
0/1 • For Low Dose cohort - study subjects were monitored for 3 days For SAD cohort - study subjects were monitored for 7 days For MAD cohort - study subjects were monitored for 21 days
|
0.00%
0/1 • For Low Dose cohort - study subjects were monitored for 3 days For SAD cohort - study subjects were monitored for 7 days For MAD cohort - study subjects were monitored for 21 days
|
16.7%
1/6 • For Low Dose cohort - study subjects were monitored for 3 days For SAD cohort - study subjects were monitored for 7 days For MAD cohort - study subjects were monitored for 21 days
|
0.00%
0/6 • For Low Dose cohort - study subjects were monitored for 3 days For SAD cohort - study subjects were monitored for 7 days For MAD cohort - study subjects were monitored for 21 days
|
0.00%
0/6 • For Low Dose cohort - study subjects were monitored for 3 days For SAD cohort - study subjects were monitored for 7 days For MAD cohort - study subjects were monitored for 21 days
|
0.00%
0/6 • For Low Dose cohort - study subjects were monitored for 3 days For SAD cohort - study subjects were monitored for 7 days For MAD cohort - study subjects were monitored for 21 days
|
16.7%
1/6 • For Low Dose cohort - study subjects were monitored for 3 days For SAD cohort - study subjects were monitored for 7 days For MAD cohort - study subjects were monitored for 21 days
|
0.00%
0/6 • For Low Dose cohort - study subjects were monitored for 3 days For SAD cohort - study subjects were monitored for 7 days For MAD cohort - study subjects were monitored for 21 days
|
0.00%
0/6 • For Low Dose cohort - study subjects were monitored for 3 days For SAD cohort - study subjects were monitored for 7 days For MAD cohort - study subjects were monitored for 21 days
|
16.7%
1/6 • For Low Dose cohort - study subjects were monitored for 3 days For SAD cohort - study subjects were monitored for 7 days For MAD cohort - study subjects were monitored for 21 days
|
|
Skin and subcutaneous tissue disorders
Skin and Subcutaneous Tissue Disorders
|
0.00%
0/1 • For Low Dose cohort - study subjects were monitored for 3 days For SAD cohort - study subjects were monitored for 7 days For MAD cohort - study subjects were monitored for 21 days
|
0.00%
0/1 • For Low Dose cohort - study subjects were monitored for 3 days For SAD cohort - study subjects were monitored for 7 days For MAD cohort - study subjects were monitored for 21 days
|
0.00%
0/1 • For Low Dose cohort - study subjects were monitored for 3 days For SAD cohort - study subjects were monitored for 7 days For MAD cohort - study subjects were monitored for 21 days
|
0.00%
0/1 • For Low Dose cohort - study subjects were monitored for 3 days For SAD cohort - study subjects were monitored for 7 days For MAD cohort - study subjects were monitored for 21 days
|
16.7%
1/6 • For Low Dose cohort - study subjects were monitored for 3 days For SAD cohort - study subjects were monitored for 7 days For MAD cohort - study subjects were monitored for 21 days
|
0.00%
0/6 • For Low Dose cohort - study subjects were monitored for 3 days For SAD cohort - study subjects were monitored for 7 days For MAD cohort - study subjects were monitored for 21 days
|
0.00%
0/6 • For Low Dose cohort - study subjects were monitored for 3 days For SAD cohort - study subjects were monitored for 7 days For MAD cohort - study subjects were monitored for 21 days
|
0.00%
0/6 • For Low Dose cohort - study subjects were monitored for 3 days For SAD cohort - study subjects were monitored for 7 days For MAD cohort - study subjects were monitored for 21 days
|
0.00%
0/6 • For Low Dose cohort - study subjects were monitored for 3 days For SAD cohort - study subjects were monitored for 7 days For MAD cohort - study subjects were monitored for 21 days
|
0.00%
0/6 • For Low Dose cohort - study subjects were monitored for 3 days For SAD cohort - study subjects were monitored for 7 days For MAD cohort - study subjects were monitored for 21 days
|
0.00%
0/6 • For Low Dose cohort - study subjects were monitored for 3 days For SAD cohort - study subjects were monitored for 7 days For MAD cohort - study subjects were monitored for 21 days
|
16.7%
1/6 • For Low Dose cohort - study subjects were monitored for 3 days For SAD cohort - study subjects were monitored for 7 days For MAD cohort - study subjects were monitored for 21 days
|
|
Vascular disorders
Vascular Disorders
|
0.00%
0/1 • For Low Dose cohort - study subjects were monitored for 3 days For SAD cohort - study subjects were monitored for 7 days For MAD cohort - study subjects were monitored for 21 days
|
0.00%
0/1 • For Low Dose cohort - study subjects were monitored for 3 days For SAD cohort - study subjects were monitored for 7 days For MAD cohort - study subjects were monitored for 21 days
|
0.00%
0/1 • For Low Dose cohort - study subjects were monitored for 3 days For SAD cohort - study subjects were monitored for 7 days For MAD cohort - study subjects were monitored for 21 days
|
0.00%
0/1 • For Low Dose cohort - study subjects were monitored for 3 days For SAD cohort - study subjects were monitored for 7 days For MAD cohort - study subjects were monitored for 21 days
|
0.00%
0/6 • For Low Dose cohort - study subjects were monitored for 3 days For SAD cohort - study subjects were monitored for 7 days For MAD cohort - study subjects were monitored for 21 days
|
0.00%
0/6 • For Low Dose cohort - study subjects were monitored for 3 days For SAD cohort - study subjects were monitored for 7 days For MAD cohort - study subjects were monitored for 21 days
|
16.7%
1/6 • For Low Dose cohort - study subjects were monitored for 3 days For SAD cohort - study subjects were monitored for 7 days For MAD cohort - study subjects were monitored for 21 days
|
16.7%
1/6 • For Low Dose cohort - study subjects were monitored for 3 days For SAD cohort - study subjects were monitored for 7 days For MAD cohort - study subjects were monitored for 21 days
|
0.00%
0/6 • For Low Dose cohort - study subjects were monitored for 3 days For SAD cohort - study subjects were monitored for 7 days For MAD cohort - study subjects were monitored for 21 days
|
16.7%
1/6 • For Low Dose cohort - study subjects were monitored for 3 days For SAD cohort - study subjects were monitored for 7 days For MAD cohort - study subjects were monitored for 21 days
|
0.00%
0/6 • For Low Dose cohort - study subjects were monitored for 3 days For SAD cohort - study subjects were monitored for 7 days For MAD cohort - study subjects were monitored for 21 days
|
33.3%
2/6 • For Low Dose cohort - study subjects were monitored for 3 days For SAD cohort - study subjects were monitored for 7 days For MAD cohort - study subjects were monitored for 21 days
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and Connective Tissue Disorders
|
0.00%
0/1 • For Low Dose cohort - study subjects were monitored for 3 days For SAD cohort - study subjects were monitored for 7 days For MAD cohort - study subjects were monitored for 21 days
|
0.00%
0/1 • For Low Dose cohort - study subjects were monitored for 3 days For SAD cohort - study subjects were monitored for 7 days For MAD cohort - study subjects were monitored for 21 days
|
0.00%
0/1 • For Low Dose cohort - study subjects were monitored for 3 days For SAD cohort - study subjects were monitored for 7 days For MAD cohort - study subjects were monitored for 21 days
|
0.00%
0/1 • For Low Dose cohort - study subjects were monitored for 3 days For SAD cohort - study subjects were monitored for 7 days For MAD cohort - study subjects were monitored for 21 days
|
0.00%
0/6 • For Low Dose cohort - study subjects were monitored for 3 days For SAD cohort - study subjects were monitored for 7 days For MAD cohort - study subjects were monitored for 21 days
|
0.00%
0/6 • For Low Dose cohort - study subjects were monitored for 3 days For SAD cohort - study subjects were monitored for 7 days For MAD cohort - study subjects were monitored for 21 days
|
0.00%
0/6 • For Low Dose cohort - study subjects were monitored for 3 days For SAD cohort - study subjects were monitored for 7 days For MAD cohort - study subjects were monitored for 21 days
|
16.7%
1/6 • For Low Dose cohort - study subjects were monitored for 3 days For SAD cohort - study subjects were monitored for 7 days For MAD cohort - study subjects were monitored for 21 days
|
16.7%
1/6 • For Low Dose cohort - study subjects were monitored for 3 days For SAD cohort - study subjects were monitored for 7 days For MAD cohort - study subjects were monitored for 21 days
|
16.7%
1/6 • For Low Dose cohort - study subjects were monitored for 3 days For SAD cohort - study subjects were monitored for 7 days For MAD cohort - study subjects were monitored for 21 days
|
0.00%
0/6 • For Low Dose cohort - study subjects were monitored for 3 days For SAD cohort - study subjects were monitored for 7 days For MAD cohort - study subjects were monitored for 21 days
|
0.00%
0/6 • For Low Dose cohort - study subjects were monitored for 3 days For SAD cohort - study subjects were monitored for 7 days For MAD cohort - study subjects were monitored for 21 days
|
|
Blood and lymphatic system disorders
Blood and Lymphatic System Disorders
|
0.00%
0/1 • For Low Dose cohort - study subjects were monitored for 3 days For SAD cohort - study subjects were monitored for 7 days For MAD cohort - study subjects were monitored for 21 days
|
0.00%
0/1 • For Low Dose cohort - study subjects were monitored for 3 days For SAD cohort - study subjects were monitored for 7 days For MAD cohort - study subjects were monitored for 21 days
|
0.00%
0/1 • For Low Dose cohort - study subjects were monitored for 3 days For SAD cohort - study subjects were monitored for 7 days For MAD cohort - study subjects were monitored for 21 days
|
0.00%
0/1 • For Low Dose cohort - study subjects were monitored for 3 days For SAD cohort - study subjects were monitored for 7 days For MAD cohort - study subjects were monitored for 21 days
|
0.00%
0/6 • For Low Dose cohort - study subjects were monitored for 3 days For SAD cohort - study subjects were monitored for 7 days For MAD cohort - study subjects were monitored for 21 days
|
0.00%
0/6 • For Low Dose cohort - study subjects were monitored for 3 days For SAD cohort - study subjects were monitored for 7 days For MAD cohort - study subjects were monitored for 21 days
|
0.00%
0/6 • For Low Dose cohort - study subjects were monitored for 3 days For SAD cohort - study subjects were monitored for 7 days For MAD cohort - study subjects were monitored for 21 days
|
0.00%
0/6 • For Low Dose cohort - study subjects were monitored for 3 days For SAD cohort - study subjects were monitored for 7 days For MAD cohort - study subjects were monitored for 21 days
|
0.00%
0/6 • For Low Dose cohort - study subjects were monitored for 3 days For SAD cohort - study subjects were monitored for 7 days For MAD cohort - study subjects were monitored for 21 days
|
16.7%
1/6 • For Low Dose cohort - study subjects were monitored for 3 days For SAD cohort - study subjects were monitored for 7 days For MAD cohort - study subjects were monitored for 21 days
|
0.00%
0/6 • For Low Dose cohort - study subjects were monitored for 3 days For SAD cohort - study subjects were monitored for 7 days For MAD cohort - study subjects were monitored for 21 days
|
0.00%
0/6 • For Low Dose cohort - study subjects were monitored for 3 days For SAD cohort - study subjects were monitored for 7 days For MAD cohort - study subjects were monitored for 21 days
|
|
Eye disorders
Eye Disorders
|
0.00%
0/1 • For Low Dose cohort - study subjects were monitored for 3 days For SAD cohort - study subjects were monitored for 7 days For MAD cohort - study subjects were monitored for 21 days
|
0.00%
0/1 • For Low Dose cohort - study subjects were monitored for 3 days For SAD cohort - study subjects were monitored for 7 days For MAD cohort - study subjects were monitored for 21 days
|
0.00%
0/1 • For Low Dose cohort - study subjects were monitored for 3 days For SAD cohort - study subjects were monitored for 7 days For MAD cohort - study subjects were monitored for 21 days
|
0.00%
0/1 • For Low Dose cohort - study subjects were monitored for 3 days For SAD cohort - study subjects were monitored for 7 days For MAD cohort - study subjects were monitored for 21 days
|
0.00%
0/6 • For Low Dose cohort - study subjects were monitored for 3 days For SAD cohort - study subjects were monitored for 7 days For MAD cohort - study subjects were monitored for 21 days
|
0.00%
0/6 • For Low Dose cohort - study subjects were monitored for 3 days For SAD cohort - study subjects were monitored for 7 days For MAD cohort - study subjects were monitored for 21 days
|
0.00%
0/6 • For Low Dose cohort - study subjects were monitored for 3 days For SAD cohort - study subjects were monitored for 7 days For MAD cohort - study subjects were monitored for 21 days
|
0.00%
0/6 • For Low Dose cohort - study subjects were monitored for 3 days For SAD cohort - study subjects were monitored for 7 days For MAD cohort - study subjects were monitored for 21 days
|
16.7%
1/6 • For Low Dose cohort - study subjects were monitored for 3 days For SAD cohort - study subjects were monitored for 7 days For MAD cohort - study subjects were monitored for 21 days
|
0.00%
0/6 • For Low Dose cohort - study subjects were monitored for 3 days For SAD cohort - study subjects were monitored for 7 days For MAD cohort - study subjects were monitored for 21 days
|
0.00%
0/6 • For Low Dose cohort - study subjects were monitored for 3 days For SAD cohort - study subjects were monitored for 7 days For MAD cohort - study subjects were monitored for 21 days
|
0.00%
0/6 • For Low Dose cohort - study subjects were monitored for 3 days For SAD cohort - study subjects were monitored for 7 days For MAD cohort - study subjects were monitored for 21 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER