Assess the safety and tolerability of single and multiple ascending doses of THB001 in addition to the effects of food in healthy volunteers.
ID
Bron
Verkorte titel
Aandoening
Preliminary safety study, first in human.
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Safety and tolerability parameters for THB001 including: physical examination, AEs, clinical laboratory values, vital signs and ECGs. PK parameters for THB001
Achtergrond van het onderzoek
This is a first-in-human study of THB001 conducted as a single ascending dose (SAD), food effect, and multiple ascending dose (MAD) evaluation of safety, tolerability, and pharmacokinetics in healthy volunteers
Doel van het onderzoek
Assess the safety and tolerability of single and multiple ascending doses of THB001 in addition to the effects of food in healthy volunteers.
Onderzoeksopzet
Screening up to -28 days, treatment period up to 17 days and a follow-up period through 77 days
Onderzoeksproduct en/of interventie
THB001 or placebo
Publiek
Steven Sweeney
+1-617-460-6141
clinical@thirdharmonicbio.com
Wetenschappelijk
Steven Sweeney
+1-617-460-6141
clinical@thirdharmonicbio.com
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
Subjects must understand the nature of the study and must provide signed and dated written informed consent in accordance with local regulations before the conduct of any study-related procedures.
Healthy as determined by the Investigator, based on a medical evaluation including medical history, physical examination, laboratory tests and ECG recording.
Men and women aged 18-65 years (inclusive) who meet all entry criteria.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
A history or presence of cancer or of a clinically significant hepatic, biliary, renal, gastrointestinal, cardiovascular, endocrine, pulmonary, ophthalmologic, immunologic, hematologic, dermatologic, or neurologic abnormality.
Evidence or history of anemia, thrombocytopenia, or leukopenia.
Use of any prescription or non-prescription drugs (excluding paracetamol), antacids, vitamins, herbal, and dietary supplements (including St John’s Wort) within 14 days (or 28 days if the drug is a potential hepatic enzyme inducer) or 5 half-lives (whichever is longer) prior to the first dose of study medication, unless in the opinion of the Investigator and Medical Monitor the medication will not interfere with the study procedures or compromise subject safety.
A positive pregnancy test (at Screening or on Day -1 of the (first) treatment period) or lactation.
A history or presence of any disease, condition, or surgery likely to affect drug absorption, distribution, metabolism, or excretion.
A clinically significant abnormality on physical examination, neurological examination, ECG, or laboratory evaluations at Screening or between Screening and (first) dose administration.
Opzet
Deelname
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In overige registers
Register | ID |
---|---|
NTR-new | NL9309 |
CCMO | NL76587.056.21 |
OMON | NL-OMON50828 |