Health TrialsbyHealthPanel

Study of Single Doses of HBS-104 in Acutely Sleep-deprived Healthy Participants

ConditionSleep Deprivation
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-55
SponsorHarmony Biosciences Management, Inc.

About this trial

This is a study to evaluate the pharmacodynamic effects, safety, tolerability, and pharmacokinetics of HBS-104 in acutely sleep-deprived healthy adult participants.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Provide written informed consent before any study-related procedures are performed.

Be healthy as determined by assessments at the Screening Visit.

Disqualifiers

Female with a positive pregnancy test at Screening Visit or upon check-in for Period 1.

Is currently breastfeeding or planning to breastfeed over the course of the study. Lactating women must agree not to breastfeed for the duration of the study and for 7 days after their final dose of study drug.

Trial design

Design model

Crossover

Treatments tested in this trial

  • HBS-104

    Drug

    Immediate-release tablets for oral use

  • Placebo

    Drug

    Matching placebo tablet

Treatment groups

12 Participants
are divided into 4 treatment groups
Group A: Crossover: HBS-104 Low DoseExperimental treatment 1 intervention
Group B: Crossover: HBS-104 Medium DoseExperimental treatment 1 intervention
Group C: Crossover: HBS-104 High DoseExperimental treatment 1 intervention
Group D: Crossover: PlaceboActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Mean Sleep Latency as Assessed by Maintenance of Wakefulness Test (MWT)

Time frame
Day 2 of each treatment period (each treatment period is 4 days in duration [Days -1 to 3]).
2

Karolinska Sleepiness Scale (KSS) Score

Time frame
Days 1 and 2 of each treatment period (each treatment period is 4 days in duration [Days -1 to 3]).
3

Psychomotor Vigilance Test (PVT) Score

Time frame
Days 1 and 2 of each treatment period (each treatment period is 4 days in duration [Days -1 to 3]).

Secondary outcomes

1

Number of Participants with Treatment Emergent Adverse Events

Time frame
Up to 25 weeks
2

Serum Concentrations of HBS-104 and Metabolites

Time frame
Days 1, 2 and 3 of each treatment period (each treatment period is 4 days in duration [Days -1 to 3]).

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Harmony Biosciences Management, Inc.

Lead sponsor

Source ClinicalTrials.gov
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