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

NCT05429788 | Withdrawn Phase 1 FDA Drug

• 1 other identifier: RC2022-01
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 3

Brief Summary

This is a Phase 1b/2a clinical trial to evaluate the safety, tolerability, and efficacy of RLS103 (cannabidiol \[CBD\] inhaled dry powder) to relieve the anxiety induced by a public speaking challenge in adults with social anxiety disorder (SAD). Subject participation will last 4 - 6 weeks. Upon signing an informed consent, all subjects will enter a screening phase lasting up to 3 weeks and including history, physical examination, laboratory tests, ECG, spirometry, and psychological tests. Subjects will undergo a public speaking test after screening tests are performed and eligibility is confirmed. One week after the completion of the public speaking test, subjects will come back for a follow-up visit that will involve a repeat of the safety and psychiatric assessments conducted during screening.

Conditions

Social Anxiety Disorder

Outcome Measures

Primary Outcomes (1)

• Incidence and severity of adverse events

  Safety and tolerability of RLS103 will be assessed by evaluating the incidence and severity of treatment emergent serious adverse events (TESAEs), treatment emergent adverse events (TEAEs), and adverse events (AEs) leading to discontinuation from the study.

  1 week (visit 3 to follow up visit)

Secondary Outcomes (2)

• Change in subject-reported anxiety

  1 week (Visit 2 to Visit 3)

• Change in CGI

  1 week (Visit 2 to Visit 3)

Other Outcomes (3)

• Changes in pulse rate in subjects with SAD

  10 minutes, assessed at Visit 2 and Visit 3

• Changes in respiratory rate in subjects with SAD

  10 minutes, assessed at Visit 2 and Visit 3

• Changes in blood pressure in subjects with SAD

  10 minutes, assessed at Visit 2 and Visit 3

Study Arms (3)

Low dose RLS103

EXPERIMENTAL

3 mg CBD inhaled dry powder

Drug: Low dose RLS103

High dose RLS103

EXPERIMENTAL

6 mg CBD inhaled dry powder

Drug: High dose RLS103

placebo

EXPERIMENTAL

placebo inhaled dry powder

Drug: placebo inhaled dry powder

Interventions

Low dose RLS103 DRUG

3 mg CBD inhaled powder administered before public speaking challenge

Low dose RLS103

High dose RLS103 DRUG

6 mg CBD inhaled powder administered before public speaking challenge

High dose RLS103

placebo inhaled dry powder DRUG

placebo inhaled powder administered before public speaking challenge

placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Male or female 18 through 65 years of age, inclusive.
• Current diagnosis of SAD as defined in the MINI.
• Clinician-rated LSAS total score ≥75 at Screening (Visit 1).
• Clinician-rated Hamilton Depression Score 17-items total score \<18 at Screening (Visit 1).
• Women of childbearing potential must commit to the consistent and correct use of an effective method of birth control throughout the study and must also have negative pregnancy test result at Screening (Visit 1), Baseline (Visit 2), and Visit 3. Effective methods of contraception include surgical sterilization of the subject, condoms with spermicide, diaphragm with spermicide, hormonal contraceptive agents (oral, transdermal, or injectable), or implantable contraceptive devices.
• Body mass index (BMI) between 18 and 32 kg/m2 (inclusive) with a body weight ≥50 kg.
• Non-smoker with no cigarettes, cigars, e-cigarettes, or nicotine-containing products used in the 1 month prior to Screening as confirmed by negative serum cotinine results (\<10 ng/mL) at Screening.
• Negative viral serology test results (HIV-1/HIV-2, hepatitis B and C virus).
• Must have no medical contraindication to CBD, including known allergies or hypersensitivities to CBD or the excipients in RLS103.
• Must demonstrate the ability to use the inhaler correctly through a training tool and must be able to tolerate inhalation of a placebo powder.
• Must have the ability and willingness to attend the necessary clinic visits.

You may not qualify if:

• Any history of bipolar disorder (I or II), schizophrenia, schizoaffective disorder, psychosis, anorexia or bulimia, premenstrual dysphoric disorder, autism-spectrum disorder, or obsessive-compulsive disorder.
• Any other current Axis I disorder, other than SAD, which is the primary focus of treatment. Note that subjects with concurrent Generalized Anxiety Disorder are eligible for the study provided that Generalized Anxiety Disorder is not the primary diagnosis.
• Subject with alcohol or substance use disorder within the 1 year prior to study entry.
• In the opinion of the Investigator, has a significant risk for suicidal behavior during the course of their participation in the study, or
• At Screening (Visit 1): the subject scores "yes" on items 1 or 2 in the C-SSRS with reference to a 6-month period prior to Screening; or
• At Screening (Visit 1): the subject has had 1 or more suicidal attempts with reference to a 2-year period prior to Screening; or
• At Visit 2 or Visit 3: the subject scores "yes" on items 1 or 2 in the Suicidal Ideation section of the C-SSRS with reference to Screening; or
• The subject is considered to be an imminent danger to themself or others.
• Two or more documented failed treatment trials with a registered medication approved for SAD, in the last three years whereby an adequate treatment trial is defined as that described in the package insert for a particular drug during which the subject received an adequate medication dosage (defined as the treatment dose indicated in the package insert to obtain efficacy for that particular drug).
• Use of any psychotropic or beta blocker medications within 14 days before study entry (other than medication permitted for insomnia: eszopiclone, ramelteon, melatonin, zaleplon, zolpidem, or antihistamines).
• Use of any over-the-counter product, prescription product, or herbal preparation for treatment of the symptoms of anxiety or social anxiety within 30 days before study entry; concomitant use is prohibited during the study.
• Pregnant or lactating at Screening or planning to become pregnant (self or partner) at any time during the study, including the follow-up period.
• Currently using marijuana, marijuana cigarettes, cannabis-related products, or CBD; or have used any of these products within 3 weeks prior to Screening (at the discretion of the Investigator in consultation with the Sponsor, to be confirmed by a urine drug test at Screening).
• Any history of pulmonary disease, including bronchospastic respiratory disease (bronchial asthma), or chronic obstructive pulmonary disease.
• Clinically significant abnormal values for ECG, chest X-ray, or spirometry, or hematology, serum chemistry, or urinalysis at Screening as deemed appropriate by the Investigator, including:

Sponsors & Collaborators

• Receptor Life Sciences: lead

Study Sites (3)

Receptor 102

Los Angeles, California, 90024, United States

Location

Receptor 105

Oceanside, California, 92056, United States

Location

Receptor 103

Torrance, California, 90502, United States

Location

MeSH Terms

Conditions

Phobia, Social

Condition Hierarchy (Ancestors)

Phobic Disorders; Anxiety Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2022
• First Posted: June 23, 2022
• Study Start: May 18, 2022
• Primary Completion: November 8, 2022
• Study Completion: November 8, 2022
• Last Updated: April 2, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)