Sleep DeprivationPhase 1NCT07848659
Study of Single Doses of HBS-104 in Acutely Sleep-deprived Healthy Participants
A Phase 1 study testing HBS-104 in people with Sleep Deprivation, run by Harmony Biosciences Management, Inc. at 1 site in United States.
Trial summary
This is a study to evaluate the pharmacodynamic effects, safety, tolerability, and pharmacokinetics of HBS-104 in acutely sleep-deprived healthy adult participants. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep Deprivation
- What is being tested?
- HBS-104
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Aug 2026to 18 Feb 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Provide written informed consent before any study-related procedures are performed.
- Be healthy as determined by assessments at the Screening Visit.
Who cannot join
- 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.
- Note: Additional inclusion/exclusion criteria may apply, per protocol
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Sponsor Clinical Site - New Jersey
Eatontown, New Jersey, 07724
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Crossover Study of the Pharmacodynamic Effects, Safety, Tolerability, and Pharmacokinetics of Single Doses of HBS 104 in Acutely Sleep-deprived Healthy Participants
This is a study to evaluate the pharmacodynamic effects, safety, tolerability, and pharmacokinetics of HBS-104 in acutely sleep-deprived healthy adult participants.
Read the detailed description
Single oral doses of HBS-104 (low, medium or high doses) or matching placebo will be administered in 4 double-blind treatment periods in a crossover design. Each treatment period is 4 days in duration (Days -1 to 3) separated by a 7 to 12 day washout interval.
- Conditions
- Sleep Deprivation
- Being tested
- HBS-104, Placebo
- Keywords
- Healthy Participants, Acute Sleep Deprivation
- Medical subject headings
- Sleep Deprivation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HBS-104Drug
Immediate-release tablets for oral use
PlaceboDrug
Matching placebo tablet
| Study group | Role | What they receive |
|---|---|---|
| Crossover: HBS-104 Low Dose | Experimental | Participants will receive a single oral low dose of HBS-104. Receives: Drug: HBS-104 |
| Crossover: HBS-104 Medium Dose | Experimental | Participants will receive a single oral medium dose of HBS-104. Receives: Drug: HBS-104 |
| Crossover: HBS-104 High Dose | Experimental | Participants will receive a single oral high dose of HBS-104. Receives: Drug: HBS-104 |
| Crossover: Placebo | Active comparator | Participants will receive a single oral dose of placebo. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Sleep Latency as Assessed by Maintenance of Wakefulness Test (MWT)
Measured: Day 2 of each treatment period (each treatment period is 4 days in duration [Days -1 to 3]).
Karolinska Sleepiness Scale (KSS) Score
Measured: Days 1 and 2 of each treatment period (each treatment period is 4 days in duration [Days -1 to 3]).
Psychomotor Vigilance Test (PVT) Score
Measured: Days 1 and 2 of each treatment period (each treatment period is 4 days in duration [Days -1 to 3]).
Secondary outcomes (2)
Number of Participants with Treatment Emergent Adverse Events
Measured: Up to 25 weeks
Serum Concentrations of HBS-104 and Metabolites
Measured: Days 1, 2 and 3 of each treatment period (each treatment period is 4 days in duration [Days -1 to 3]).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2026
- Study start28 Aug 2026
- Primary completion30 Oct 2026 (estimated)
- Study completion18 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep DeprivationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Harmony Biosciences Management, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Sneiden, MD, Study director, Harmony Biosciences Management, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07848659
- Sponsor's protocol ID
- HBS-104-CL-101
- Status last verified
- Sep 2026
- First submitted
- 9 Sep 2026
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Crossover Study of the Pharmacodynamic Effects, Safety, Tolerability, and Pharmacokinetics of Single Doses of HBS 104 in Acutely Sleep-deprived Healthy Participants
- ClinicalTrials.gov ID
- NCT07848659
- Acronym / sponsor ID
- HBS-104-CL-101
- Conditions
- Sleep Deprivation
- Keywords
- Healthy Participants, Acute Sleep Deprivation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Harmony Biosciences Management, Inc.Industry (pharma, biotech, devices)
- Study start
- 28 Aug 2026 (actual)
- Primary completion
- 30 Oct 2026 (estimated)
- Study completion
- 18 Feb 2027 (estimated)
- First posted
- 30 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a study to evaluate the pharmacodynamic effects, safety, tolerability, and pharmacokinetics of HBS-104 in acutely sleep-deprived healthy adult participants.
Detailed description
Single oral doses of HBS-104 (low, medium or high doses) or matching placebo will be administered in 4 double-blind treatment periods in a crossover design. Each treatment period is 4 days in duration (Days -1 to 3) separated by a 7 to 12 day washout interval.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Crossover: HBS-104 Low Dose | Experimental | Drug: HBS-104Participants will receive a single oral low dose of HBS-104. |
| Crossover: HBS-104 Medium Dose | Experimental | Drug: HBS-104Participants will receive a single oral medium dose of HBS-104. |
| Crossover: HBS-104 High Dose | Experimental | Drug: HBS-104Participants will receive a single oral high dose of HBS-104. |
| Crossover: Placebo | Active comparator | Drug: PlaceboParticipants will receive a single oral dose of placebo. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Provide written informed consent before any study-related procedures are performed.
- Be healthy as determined by assessments at the Screening Visit.
Key exclusion criteria (3 listed)
- 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.
- Note: Additional inclusion/exclusion criteria may apply, per protocol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HBS-104Immediate-release tablets for oral use | Drug | Crossover: HBS-104 High Dose, Crossover: HBS-104 Low Dose, Crossover: HBS-104 Medium Dose |
| PlaceboMatching placebo tablet | Drug | Crossover: Placebo |
Primary outcome
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]).
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]).
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]).
2 secondary outcomes
Number of Participants with Treatment Emergent Adverse Events
Time frame: Up to 25 weeks
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]).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
David Sneiden, MD study director
Harmony Biosciences Management, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HBS-104 in people with Sleep Deprivation, run by Harmony Biosciences Management, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Trials Administrator (see email, clinicaltrials@harmonybiosciences.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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]).). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2026.