Safety and Pharmacokinetic Study of OMT-28 in Healthy Subjects

OMEICOS Therapeutics

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Other: Matching Placebo; Drug: OMT-28

Study type: Interventional

Funder types: Industry

Identifiers

NCT03078738

OMT28-C0101

Details and patient eligibility

About

The aim of this first-in-human study is to assess the safety, tolerability, PK and exploratory pharmacodynamics (PD) of single and multiple oral ascending doses of OMT-28 in healthy male subjects to support further clinical development of OMT-28 in the indication of atrial fibrillation (AF) and to obtain data on food and gender effects of OMT-28 to guide dosing for Phase II trials.

Full description

This first-in-human study will be carried out in one study center involving multiple steps. Up to 100 healthy male and female subjects will be enrolled. The study consists of 4 parts:

1. a single ascending dose (SAD) part
2. a multiple ascending dose (MAD) part
3. a single dose, double cross-over food effect (FE) part.
4. a single dose gender effect part (female subjects group) The safety and PK data will be evaluated by the DSMC after each cohort to decide on further dose escalation.

Enrollment: 75 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. In general good physical health as determined by medical and surgical history, physical examination, 12 lead ECG, vital signs, and clinical laboratory tests
2. Normal blood pressure (Systolic Blood Pressure (SBP) between 100 to 140 mmHg (both inclusive); Diastolic Blood Pressure (DBP) ≥55, ≤89 mmHg) measured after 5 min rest in supine position.
3. SAD, MAD, and FE part: male of 18 to 45 years (inclusive) of age.
4. Gender effect part: female of 18 to 45 years (inclusive) of age.

Exclusion criteria

1. More than moderate smoker (> 10 cigarettes/day).
2. More than moderate alcohol consumption (> 35 g of ethanol regularly per day or > 245 g regularly per week).
3. Use of any medication
4. One or more key safety laboratory parameters out of normal range Gender effect part Pregnant or breastfeeding women and of childbearing potential Previous assignment to treatment during this study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Triple Blind

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75 participants in 7 patient groups, including a placebo group

OMT-28-SAD

Experimental group

Description:

OMT-28-SAD, Single ascending dose levels 1 - 3 of OMT-28 (15, 30, 60 mg) Oral, healthy young male

Treatment:

Drug: OMT-28

OMT-28-MAD

Experimental group

Description:

Multiple ascending dose of dose levels 1 - 3 of OMT-28 over 14 days (4, 12, 36 mg) Oral, healthy young male

Treatment:

Drug: OMT-28

OMT-28- Food Effect

Experimental group

Description:

Single dose of OMT-28 (4 mg) Oral, healthy young male

Treatment:

Drug: OMT-28

OMT-28-Gender

Experimental group

Description:

Single dose of OMT-28 (4 mg) Oral, healthy non-child bearing potential female

Treatment:

Drug: OMT-28

Placebo-SAD

Placebo Comparator group

Description:

Single dose levels 1 - 3 of matching placebo, Oral, healthy young male

Treatment:

Other: Matching Placebo

Placebo MAD

Placebo Comparator group

Description:

Multiple dose levels 1 - 3 of matching placebo over 14 days Oral, healthy young male

Treatment:

Other: Matching Placebo

Placebo-Gender

Placebo Comparator group

Description:

Single dose of matching Placebo Oral, healthy non-child bearing potential female

Treatment:

Other: Matching Placebo