Safety, Tolerability, and Efficacy of RLS103 in Subjects With Acute Anxiety Within Social Anxiety Disorder (SAD)

Recruiting at 2 trial locations

Overseen By Tiffany Smith

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Receptor Life Sciences

Must not be taking: Psychotropics, Beta blockers

Disqualifiers: Bipolar, Schizophrenia, Substance use, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 1 day

Trial Summary

What is the purpose of this trial?

This trial is testing an inhaled CBD powder to help adults with social anxiety disorder feel less anxious during public speaking. The treatment works by calming the brain. The study will check if this method is safe and effective over several weeks. Cannabidiol (CBD) has been shown to reduce anxiety in various settings, including public speaking and treatment-resistant anxiety disorders.

Will I have to stop taking my current medications?

Yes, you will need to stop taking any psychotropic or beta blocker medications at least 14 days before joining the study. Additionally, you cannot use any over-the-counter products, prescription products, or herbal preparations for anxiety or social anxiety within 30 days before the study and during the study.

What data supports the effectiveness of the drug RLS103?

The research on rhTRAIL, a component related to RLS103, shows it can effectively induce cell death in various cancer cells by targeting specific receptors on the cells. This suggests that RLS103 might also be effective in similar ways, especially if it involves similar mechanisms. ^{1 2 3 4 5}

Eligibility Criteria

Inclusion Criteria

Must sign an informed consent form (ICF) indicating that they understand the purpose of the study and the procedures required for the study and are willing to participate in the study and attend all visits and requirements.

Current diagnosis of SAD as defined in the MINI.

Clinician-rated Hamilton Depression Score 17-items total score <18 at Screening (Visit 1).

Timeline

Screening

Participants are screened for eligibility to participate in the trial

up to 3 weeks

1 visit (in-person)

Treatment

Participants undergo a public speaking test after screening tests are performed and eligibility is confirmed

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, involving a repeat of the safety and psychiatric assessments conducted during screening

1 week

1 visit (in-person)

Treatment Details

Interventions

• RLS103

Participant Groups

Group I: placebo Experimental Treatment 1 Intervention

placebo inhaled dry powder

Group II: Low dose RLS103 Experimental Treatment 1 Intervention

3 mg CBD inhaled dry powder

Group III: High dose RLS103 Experimental Treatment 1 Intervention

6 mg CBD inhaled dry powder

Who Is Running the Clinical Trial?

Receptor Life Sciences

Lead Sponsor

Trials

2

Recruited

2+

Findings from Research

The phase I study of OPB-31121, an oral STAT3 inhibitor, involved 25 patients with advanced solid tumors and established a maximum-tolerated dose (MTD) of 800 mg/day, demonstrating that the drug is safe and relatively well tolerated.

Preliminary results indicated some antitumor activity, with two patients experiencing tumor shrinkage and eight patients maintaining stable disease, suggesting potential efficacy in treating advanced solid tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase I Study of OPB-31121, an Oral STAT3 Inhibitor, in Patients with Advanced Solid Tumors. Oh, DY., Lee, SH., Han, SW., et al.[2022]

References

1. Korea (South) pubmed.ncbi.nlm.nih.gov

Phase I Study of OPB-31121, an Oral STAT3 Inhibitor, in Patients with Advanced Solid Tumors. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Enhancement of antitumor properties of rhTRAIL by affinity increase toward its death receptors. [2013]

3. United States pubmed.ncbi.nlm.nih.gov

TRAIL induces apoptosis in oral squamous carcinoma cells--a crosstalk with oncogenic Ras regulated cell surface expression of death receptor 5. [2021]

4. Germany pubmed.ncbi.nlm.nih.gov

Phase 1, open-label, dose-escalation, and pharmacokinetic study of STAT3 inhibitor OPB-31121 in subjects with advanced solid tumors. [2014]

5. Switzerland pubmed.ncbi.nlm.nih.gov

STAT3 Inhibitor ODZ10117 Suppresses Glioblastoma Malignancy and Prolongs Survival in a Glioblastoma Xenograft Model. [2021]