Subcutaneous Administration of MD-18 in Healthy Subjects

Cohen Global

Status and phase: Active, not recruiting; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: MD-18

Study type: Interventional

Funder types: Industry

Identifiers

NCT06259903

MD-18-01

Details and patient eligibility

About

A Single Center, Single Dose, Double-blind, Randomized, Placebo-controlled Dose-Escalating Study to Evaluate Safety, Tolerability and Pharmacokinetics of Subcutaneously Administered MD-18 in healthy subjects.

Full description

This study will be conducted as a single-center study. A single escalating dose of MD-18 will be administered to each subject with a seven-day follow-up. 35 subjects will be enrolled. Cohorts will receive doses of 40. 80, 160, 240 or 320 milligram of MD-18 using 5:2 (active: placebo) randomization. Sentinel dosing will be used, consisting of enrolling three subjects at a 2:1 active to placebo ratio followed by the remaining subjects in the respective dose cohorts enrolled 48 hours later. Each of the 5 dose cohorts will enroll five active and two placebo subjects, with a total of 25 subjects receiving active therapy across the 5 arms and 10 subjects receiving placebo. The study will be conducted on an in-patient basis for the first 24 hours, followed by discharge and telephone check-in at 48 and 72 hours and return for follow-up visit at 7 days after administration of a single dose of MD-18.

Enrollment: 35 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Subjects aged 18-70 years, both genders.

2. Healthy as determined by a physician, based on history, medical examination, vital signs, laboratory tests, cardiac monitoring and respiratory function. History must comply with the following:

   1. Absence of clinically significant illness or surgery within the preceding 12 weeks.
   2. Absence of clinically significant history of neurological, endocrine, cardiovascular, pulmonary, hematological, immunologic, psychiatric, gastrointestinal, renal, hepatic, and/or metabolic disease.

3. Male subjects with female partners of childbearing potential must agree to utilize an approved contraceptive during the study.

4. Female subjects of child-bearing potential with negative urine pregnancy tests and who agree to use contraception during the study.

5. Female subjects of non-child-bearing potential (i.e. tubal ligation, hysterectomy, or postmenopausal).

6. Body mass index (BMI) of 18.5-39.9 kg/m2

Exclusion criteria

1. History of excessive alcohol use (defined as >21 drinks per week for males and >14 drinks per week for females), recreational drug use or drugs of abuse within the past three months, or failure on urinary drug screen. Note: use of Cannabinoids for medical purposes is allowed.
2. Pregnant or breastfeeding within six months of screening assessment.
3. Substantial changes in eating habits or exercise routine within the preceding three months.
4. Evidence of eating disorders.
5. >5% weight change in the past three months.
6. Bariatric surgery within the past five years.
7. Significant renal impairment glomerular filtration rate (GFR) <60 milligram/milliliter/1.73m2).
8. Liver function tests (i.e., alanine aminotransferase, Aspartate Amino Transferase, alkaline phosphatase) greater than twice the upper limit of normal upon repeated measurements.
9. Diseases interfering with metabolism and/or ingestive behavior (e.g., myxedema, Cushing's disease, schizophrenia, major psychoses, unmanaged depression).
10. Use of drugs approved for the treatment of obesity.
11. Any clinically significant abnormality following the Investigator's review of the physical examination and clinical laboratory tests.
12. A baseline prolongation of ventricular activation and recovery interval after repeated measurements of >450 millisecond; a history of unexplained syncope, cardiac arrest, unexplained cardiac arrhythmias or torsades de pointes, structural heart disease, or a family history of Long QT Syndrome (LQTS).
13. Participation in an investigational drug trial within three months prior to dosing in the present study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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35 participants in 5 patient groups

40 milligram (mg) MD-18 OR 40 milligram(mg) Placebo

Experimental group

Description:

A single dose of subcutaneous injection of 40mg MD-18 OR 40mg Placebo will be given on day zero.

Treatment:

Drug: MD-18

80 milligram (mg) MD-18 OR 80 milligram (mg) Placebo

Experimental group

Description:

A single dose of subcutaneous injection of 80mg MD-18 OR 80mg Placebo will be given on day zero.

Treatment:

Drug: MD-18

160 milligram (mg) MD-18 OR 160 milligram (mg) Placebo

Experimental group

Description:

A single dose of subcutaneous injection of 160mg MD-18 OR 160mg Placebo will be given on day zero.

Treatment:

Drug: MD-18

240 milligram (mg) MD-18 OR 240 milligram (mg) Placebo

Experimental group

Description:

A single dose of subcutaneous injection of 240mg MD-18 OR 240mg Placebo will be given on day zero.

Treatment:

Drug: MD-18

320 milligram (mg)MD-18 OR 320 milligram (mg) Placebo

Experimental group

Description:

A single dose of subcutaneous injection of 320mg MD-18 OR 320mg Placebo will be given on day zero.

Treatment:

Drug: MD-18