A Study to Evaluate the Pharmacokinetics (PK), Safety and Tolerability of Single- and Multiple-Ascending Doses of MH-001 in Healthy Volunteers

Vespina Lifesciences Inc.

Status and phase: Enrolling; Phase 1

Conditions: Healthy

Treatments: Drug: Placebo; Drug: MH-001

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06780254

MH001-01

Details and patient eligibility

About

First-in-Human study to demonstrate the safety and tolerability of single- and multiple-ascending doses of MH-001 in Healthy Volunteers (HVs)

Enrollment: 64 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Male or non-childbearing potential Female, non smoker, with a Body Mass Index (BMI) between 18.5 and 32.0 kilogram per meter square (kg/m2) and red blood cells greater or equal (≥) to 120 grams per liter (g/L) for women and ≥135 g/L for men
• In good health, determined by no clinically significant findings of skin, dental, neurological, endocrine, cardiovascular, respiratory, hematological, immunological, psychiatric, gastrointestinal, renal, hepatic, and metabolic disease

Exclusion criteria

• Have a history or presence of clinically significant medical illness including, but not limited to, any cardiovascular, hepatic, respiratory, hematological, chronic or relevant acute infections, relevant immunodeficiency, renal, endocrine, psychiatric or neurological disease, or any clinically significant laboratory abnormality that, in the judgment of the Investigator, indicates a medical problem that would preclude study participation.
• History of skin disorders including clinically significant active skin disease.
• History/signs and symptoms of current or recurrent teeth and gums disease
• Clinically significant abnormal laboratory test results or positive hepatitis panel and/or positive human immunodeficiency virus test.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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64 participants in 2 patient groups, including a placebo group

MH-001

Experimental group

Description:

In each cohort, 6/8 participants will be exposed to 1 or multiple administrations of a specific dosage of MH-001

Treatment:

Drug: MH-001

Placebo

Placebo Comparator group

Description:

In each cohort, 2/8 participants will be exposed to 1 or multiple administrations of a placebo

Treatment:

Drug: Placebo