Study to Evaluate the Safety, Tolerability, and Pharmacokinetics in Healthy Volunteers of the Novel Self-Administered Intranasal CG- SpikeDown Antiviral Drug

NCT05234320 | Unknown Phase 1 DMC

• 1 other identifier: CG-S-P01
• Study Type: interventional
• Target: 16
• Locations: 0 countries
• Sites: N/A

Brief Summary

Study Design This is a phase 1, randomized, Vehicle-controlled, double-blinded study to assess the safety of Caregen Intranasal CG-SpikeDown in healthy subjects. All randomized subjects will receive an active drug or Vehicle. Subjects randomized to the DP(Drug product) active treatment will receive CG- SpikeDown intranasally once daily for one or seven days at either a low (25 mg) or planned (50 mg) dose. Subject recruitment will be conducted via study advertisement on social media, and subjects will be adequately compensated. The subjects will arrive each day at the clinic to receive the treatment and will be hospitalized for safety monitoring for the first 24 hours post-DP or vehicle administration.

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• SARS Cov-2 RT-PCR test

  Viral load is estimated from nasopharyngeal swabs and instructions for use is based on the package insert of the diagnostic. This assessment will be used to diagnose COVID-19 patients during Stage II in case they do not have a positive COVID-19 test result from 72 hours before the Stage II screening visit, and will also be used to assess viral load in COVID-19 patients during Stage II.

  7 days

• Area under the plasma concentration versus time curve

  The following PK parameters evaluation collected 10 minutes prior to DP self-administration, immediately following DP self-administration, and 1, 2, 4 and 6 hours following DP self-administration, on Day 1 and Day 6 of treatment. These measurements will be collected only during Stage I (from 10 healthy subjects)

  7 days

Secondary Outcomes (2)

• NIAID ordinal scale

  14 days

• Peak Plasma Concentration

  7 days

Other Outcomes (1)

• Time to maximum plasma concentration

  7 days

Study Arms (4)

stage I- Healty

EXPERIMENTAL

The first 2 patients in this stage will receive the vehicle treatment and will not undergo the first 24 hour hospitalization. The 3rd and 4th patients will receive a lower dose of 12.5 mg of the DP once daily for 7 days, and the first 24 hours will be hospitalized for the first 24 hours. The 5th patient will receive the 25 mg from the DP once daily for 7 days and will be hospitalized for the first 24 hours. The next 2 patients will receive the 25 mg dose and will not undergo the first 24 hour hospitalization. The next 3 patients will receive the optimal dose of 50 mg and will not undergo the first 24 hour hospitalization

Drug: CG-SpikeDown, intranasal formulation

Stage II- Placebo + SOC

ACTIVE COMPARATOR

This arm will be include 20 This arm will be include 20 symptomatic non-hospitalized COVID-19 patients and will be conducted at patients' homes during their self-isolation, and they will be received Placebo + standard of care

Drug: Vehicle (Placebo); Drug: Standard of core (type of therapy is depend of decide of the site)

Stage II- DP low dose (25 mg) + SOC

ACTIVE COMPARATOR

This arm will be include 20 symptomatic non-hospitalized COVID-19 patients and will be conducted at patients' homes during their self-isolation, and they will be received Drug product low does(25 mg) + standard of care

Drug: CG-SpikeDown, intranasal formulation; Drug: Vehicle (Placebo); Drug: Standard of core (type of therapy is depend of decide of the site)

Stage II- DP planned dose (50 mg) + SOC

ACTIVE COMPARATOR

This arm will be include 20 This arm will be include 20 symptomatic non-hospitalized COVID-19 patients and will be conducted at patients' homes during their self-isolation, and they will be received Drug product planned does(50 mg) + standard of care

Drug: CG-SpikeDown, intranasal formulation; Drug: Vehicle (Placebo); Drug: Standard of core (type of therapy is depend of decide of the site)

Interventions

CG-SpikeDown, intranasal formulation DRUG

The CG-SpikeDown peptide produces a dose-dependent increase in binding to the receptor binding domain (RBD) of the SARS-CoV-2 spike protein and a dose-dependent inhibition of SARS-CoV-2 protein binding to ACE2, the key cellular target. A similar inhibition of binding to ACE2 in human alveolar basal epithelial cells has been demonstrated.

Stage II- DP low dose (25 mg) + SOC; Stage II- DP planned dose (50 mg) + SOC; stage I- Healty

Vehicle (Placebo) DRUG

patients will receive active drug or placebo in addition to standard of care

Stage II- DP low dose (25 mg) + SOC; Stage II- DP planned dose (50 mg) + SOC; Stage II- Placebo + SOC

Standard of core (type of therapy is depend of decide of the site) DRUG

patients will receive active drug or placebo in addition to standard of care

Stage II- DP low dose (25 mg) + SOC; Stage II- DP planned dose (50 mg) + SOC; Stage II- Placebo + SOC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years in healthy condition
• Able and willing to sign ICF

You may not qualify if:

• Known hypersensitivity to any of the DP ingredients.
• Pregnant or lactating woman.
• Participation in another clinical study within 4 weeks from screening
• Patient has a positive test for HBV, HCV or HIV
• Subjects diagnosed with allergic rhinitis and/or deviated septum and/or sinusitis.
• Any medical condition that in the investigator's opinion will jeopardize the patient's ability to follow the protocol.
• Age ≥ 18 years
• Laboratory confirmed SARS-CoV2 Infection by nasopharyngeal RT-PCR.
• COVID-19 symptoms within 3 days of symptoms onset
• Patients diagnosed with COVID-19 that are not hospitalized (classified on the NIAID 8-point ordinal scale as 1 or 2).
• Patients who may require hospitalization during the study
• Immunocompromised COVID-19 patients.
• Known hypersensitivity to any of the DP ingredients.
• Patient has a positive test for HBV, HCV or HIV
• Pregnant or lactating woman.

Sponsors & Collaborators

• Caregen Co. Ltd.: lead

Central Study Contacts

Chen Binyamin, B.Sc

CONTACT

050-467-2545; chen.b@technostat.co.il

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The study will begin with recruitment for the single 25 mg dose arm /vehicle arm, and once all subjects have been treated and attended their first follow-up visit with no significant safety issues, recruitment of participants for the single 50 mg dose arm/vehicle arm and the multiple 25 mg dose arm/vehicle arm. Once subjects from the multi 25 mg dose Cohort have attended their follow-up visit with no significant safety issues, recruitment for the final multiple 50 mg dose arm/vehicle arm may commence.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A Phase 1, Randomized, Double-blinded, Vehicle-controlled, Single and Multi-Dose, Dose Escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetics

Study Record Dates

• First Submitted: February 6, 2022
• First Posted: February 10, 2022
• Study Start: October 1, 2022
• Primary Completion: January 1, 2023
• Study Completion: January 1, 2023
• Last Updated: September 22, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share