This study is designed to evaluate the safety, tolerability, and pharmacokinetics (PK) of OLX72021 in medically healthy men with mild to moderate androgenetic alopecia.
This is a Phase 1b/2a double-blind, randomized, placebo-controlled, multiple ascending dose study evaluating the safety, efficacy, and pharmacokinetics (PK) of OLX72021 at a maximum of 2 dose levels. In Phase 1b, evaluation of dose levels will be conducted in a sequential manner with lower dose levels evaluated first in the sequence. Each dose level will be evaluated in a cohort of 12 participants with 9 participants receiving OLX72021 and 3 participants receiving placebo, approximately 24 participants in total. Cohorts may be dosed concurrently in Phase 2a. Each dose level will be evaluated in approximately 134 participants receiving OLX72021 or placebo for Phase 2a.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
158
Emeritus Research Camberwell
Camberwell, Victoria, Australia
RECRUITINGTo investigate the incidence, type, severity, and relationship of adverse events (AEs)/serious AEs (SAEs), assessed using the CTCAE Version 5.0 (Phase 1b)
Time frame: From baseline to end of study (Day 85)
To assess local tolerability at intradermal (ID) injection site (Phase 1b)
Time frame: From baseline to end of study (Day 85)
To evaluate the change from baseline in non-vellus Target Area Hair Count (TAHC) at 24 weeks (Day 169) (Phase 2a)
Time frame: Baseline to Day 169
To measure time to plasma Cmax (Tmax) (Phase 1b)
Time frame: From baseline to Day 58
To measure maximum observed plasma concentration (Cmax) (Phase 1b)
Time frame: From baseline to Day 58
To measure area under the plasma concentration-time curve from 0 to time of last quantifiable concentration (AUClast) (Phase 1b)
Time frame: From baseline to Day 58
To measure area under the plasma concentration-time curve from 0 to infinity (AUCinf) (Phase 1b)
Time frame: From baseline to Day 58
To measure apparent terminal elimination half-life (t1/2) (Phase 1b)
Time frame: From baseline to Day 58
To measure total apparent body clearance (CL/F) (Phase 1b)
Time frame: From baseline to Day 58
To measure apparent volume of distribution (Vz/F) (Phase 1b)
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Placebo
Time frame: From baseline to Day 58
To evaluate the change from baseline in non-vellus Target Area Hair Count (TAHC) at Day 29, Day 57, Day 85, Day 113, and Day 141 (Phase 2a)
Time frame: From baseline to Day 141
To investigate the incidence, type, severity, and relationship of adverse events (AEs)/serious AEs (SAEs) (Phase 2a)
Time frame: From baseline to end of study (Day 169)
To investigate the local tolerability at intradermal (ID) injection site (Phase 2a)
Time frame: From baseline to end of study (Day 169)