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

NCT05234320 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2022-09-22

No results posted yet for this study

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

Interventions

DRUG

CG-SpikeDown, intranasal formulation

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.

DRUG

Vehicle (Placebo)

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

DRUG

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

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

Sponsors & Collaborators

  • Caregen Co. Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-10-31
Primary Completion
2023-01-31
Completion
2023-01-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05234320 on ClinicalTrials.gov