A Phase 1, First Time in Humans Study of NST-1024

• Status: Recruiting
• Trial end date: 2021-12-30
• Target enrollment: 0
• Participant gender: All

Summary

A first time in man study of NST-1024

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: NorthSea Therapeutics B.V.

Criteria

Inclusion Criteria:

• BMI 18-32 kg/m2

• In good health

• Females will not be pregnant or lactating. Females of childbearing potential must agree to use contraception

• Male subjects must agree to use contraception and refrain from donation of sperm

• Able to comprehend and willing to sign an ICF and to abide by the study restrictions.

• Subjects must have TG levels > 150 mg/dL at screening (Part B only).

Exclusion Criteria:

• Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, haematological, pulmonary, CV, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the Investigator (or designee).

• History of febrile illness within 7 days prior to the first dose of study drug or subjects with evidence of active infection.

• History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (uncomplicated appendectomy and hernia repair will be allowed).

• Aspartate aminotransferase, ALT, GGT, ALP, or total bilirubin > 1.2 × ULN at Screening or (first) Check-in, confirmed by 1 repeat if necessary

• History of alcoholism or drug/chemical abuse within 2 years prior to Check-in.

• Participation in a clinical study involving administration of an investigational drug (new chemical entity) in the past 90 days or 5 half-lives (whichever is longer) prior to dosing.

• Use of tobacco- or nicotine-containing products within 1 month prior to Screening, or positive cotinine test at Screening or Check-in.