Healthy Volunteers (Part 1) Clinical Trial
Official title:
A Two-part Study: Part 1 is a Multiple-dose (7-day), Open-label Evaluation of the Safety, Tolerability, and Pharmacokinetics of HT-2157 in Healthy Subjects. Part 2 is a Randomized, Double-blind, Placebo-controlled, Multiple (21-day) Ascending-dose Evaluation of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HT-2157 in Patients With Major Depressive Disorder
This is a two part study. The objective of Part 1 is to evaluate the safety, tolerability,
and pharmacokinetics of HT-2157 in healthy normal volunteers
Part 2 is a randomized, double-blind, placebo-controlled, multiple (21-day) ascending-dose
evaluation of the safety, tolerability, pharmacokinetics, and pharmacodynamics of HT-2157 in
patients with major depressive disorder
This is a two part study. The objective of Part 1 is to evaluate the safety, tolerability,
and pharmacokinetics of HT-2157 administered for 7-days in healthy normal volunteers
Part 2 is a randomized, double-blind, placebo-controlled, multiple ascending-dose evaluation
of the safety, tolerability, pharmacokinetics of HT-2157 administered for 21-days in
patients with major depressive disorder. The primary objective of Part 2 is to assess the
CNS penetration of HT-2157 in cerebrospinal fluid. In addition, the potential activity of
HT-2157 in this patient population may be assessed using exploratory biologic and
pharmacodynamic markers of potential efficacy
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Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science