Health TrialsbyHealthPanel

Phase 1 Study of SBS-147 in Healthy Adults

ConditionsPain AcutePain
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-55
SponsorSparian Biosciences, Inc

About this trial

This study is part of the HEAL Initiative supported by the NIH.

The purpose of this study is to learn how safe the study drug, SBS-147, is and how people's bodies respond to and process it. Researchers will also look for any side effects that may occur when taking SBS-147.

Some participants will receive SBS-147, and others will receive a placebo, which looks the same but does not contain any medicine. This helps researchers fairly compare results.

The study includes two parts:

Single-Dose Group, where Participants receive SBS-147 or placebo one time.

Multiple-Dose Group, where Participants receive SBS-147 or placebo once or twice daily for 7 days.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Provision of signed and dated informed consent form (ICF)

Healthy adult male or female, aged 18 to 55 years, inclusive, at Screening

Body mass index (BMI) within 18.0 kg/m2 to 32.0 kg/m2 inclusively

Minimum body weight of at least 50.0 kg at Screening

Disqualifiers

Female who is lactating at Screening

Female who is pregnant

History of significant hypersensitivity reactions (like angioedema) to any drugs

Presence or history of significant surgery that may affect drug bioavailability

Trial design

Design model

Sequential

Treatments tested in this trial

  • SBS-147

    Drug

    Experimental therapeutic

  • Placebo

    Drug

    Placebo comparator

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Single Ascending DoseExperimental treatment 2 interventions
Group B: Multiple Ascending DoseExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

To assess the number of treatment emergent adverse events experienced in participants after a single dose of SBS-147

Time frame
8 days
2

Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 at ascending doses

Assess the number of treatment emergent adverse events experienced by participants of SBS-147 after multiple dose oral administration in healthy adults.

Time frame
14 days

Secondary outcomes

1

Relative plasma exposure of SBS-1000 compared with SBS-147 (SAD)

Geometric mean ratios (SBS-1000 / SBS-147) for Cmax and AUC

Time frame
0-12 hours, 0-24 hours, and extrapolated to infinity after dosing
2

Plasma pharmacokinetics of SBS-1000 and SBS-147 following multiple ascending doses

Plasma concentrations of SBS-1000 and SBS-147 will be analyzed using noncompartmental methods to characterize single-dose and steady-state pharmacokinetics.

Time frame
Day 1 (single-dose PK) and Day 7 at steady state over the dosing interval (τ)

Other outcomes

Sponsors and contacts

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

Sparian Biosciences, Inc

Lead sponsor

National Institutes of Health (NIH)

Collaborator

Altasciences Company Inc.

Collaborator

Source ClinicalTrials.gov
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