HealthyPhase 1NCT05234320
Study to Evaluate the Safety, Tolerability, and Pharmacokinetics in Healthy Volunteers of the Novel Self-Administered Intranasal CG- SpikeDown Antiviral Drug
A Phase 1 study testing CG-SpikeDown, intranasal formulation and Standard of core (type of therapy is depend of decide of the site) in people with Healthy, run by Caregen Co. Ltd..
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- CG-SpikeDown, intranasal formulation and Standard of core (type of therapy is depend of decide of the site)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- No sites listed yet
- Study dates
- Oct 2022to Jan 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Stage I Inclusion Criteria
- Age ≥ 18 years in healthy condition
- Able and willing to sign ICF
Stage I Exclusion Criteria
- 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.
Stage II Inclusion Criteria
- 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).
Stage II Exclusion Criteria
- 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.
- Participation in another clinical study within 4 weeks from screening
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Phase 1, Randomized, Double-blinded, Vehicle-controlled, Single and Multi-Dose, Dose Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics in Healthy Volunteers of the Novel Self-Administered Intranasal CG- SpikeDown Antiviral Drug
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.
Read the detailed description
This is a phase 1, Randomized, Double-blinded, Vehicle-controlled, Single and Multi-Dose, Dose Escalation Study, which will assess the safety of the Caregen CG-SpikeDown drug self-administered intranasally, for healthy subjects.
The study will include 16 healthy subjects and will be conducted in a clinic under complete supervision of the clinical team. The study will start with evaluation of the lowest dose, that will be increased gradually as long as no safety issues arise.
At the first stage of the study, three (3) subjects will be randomized in a 1:2 ratio to receive vehicle treatment or the active drug, respectively. Each of the 3 subjects will receive a single 25 mg dose of the assigned treatment. These subjects will be referred as Cohort 1. If no safety issues arise, the study will proceed simultaneously to the second and third stages, as depicted in Figure 1 Study Flow Chart.
At the second stage of the study, additional three (3) subjects will be enrolled and randomized in a 1:2 ratio to receive vehicle treatment or the active drug, respectively. Each of the 3 subjects will receive a single 50 mg dose of the assigned treatment. These subjects will be referred as Cohort 2. If no safety issues arise, the study will proceed to the 4th stage.
At the third stage of the study, additional three (5) subjects will be enrolled. The first 2 subjects (out of the 5 subjects) will receive an open label DP treatment-a daily 25 mg dose for 7 days. The open-label subjects will undergo PK assessments as described in the SOA. The next 3 subjects will be randomized in a 1:2 ratio to receive vehicle treatment or the active drug, respectively. Each of the 3 subjects will receive a daily 25 mg dose of the assigned treatment for 7 days. These subjects will be referred as Cohort 3.
At the fourth stage of the study, additional three (5) subjects will be enrolled. The first 2 subjects (out of the 5 subjects) will receive an open label DP treatment-a daily 50 mg dose for 7 days. The open-label subjects will undergo PK assessments as described in the SOA. The next 3 subjects will be randomized in a 1:2 ratio to receive vehicle treatment or the active drug, respectively. Each of the 3 subjects will receive a daily 50 mg dose of the assigned treatment for 7 days. These subjects will be referred as Cohort 4.
The main objective of this study is to assess the toxicity and the pharmacokinetic (PK) parameters of the Drug Product (DP). Subjects will be recruited to the study via study advertisement on social media and the subjects will be adequately compensated. The DP will be self-administered intranasally once daily for 1 day or seven days, depending on the study cohort. PK parameters will be evaluated for 4 subjects participating in the 7 daily DP doses study cohorts. Blood samples for this purpose will be collected at several time points (as described in SOA) during Day 1 and Day 7 of treatment. Toxicity will be evaluated during the entire study period.
Patients receiving a single dose will arrive for a follow-up visit 72 hours following DP administration (24 hours following hospital discharge), again 7 days (+-2 days) following DP administration, and again 14 days (+-2 days) following DP administration. Subjects receiving a daily dose for 7 days will be followed up 14 days (+-2 days) following initial DP administration (7 days (+-2 days) following final DP administration).
Safety review by the DSMB will occur following treatment of the last subject in each study arm.
- Conditions
- Healthy
- Being tested
- CG-SpikeDown, intranasal formulation, Vehicle (Placebo), Standard of core (type of therapy is depend of decide of the site)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CG-SpikeDown, intranasal formulationDrug
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.
Vehicle (Placebo)Drug
patients will receive active drug or placebo in addition to standard of care
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: 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 Receives: Drug: CG-SpikeDown, intranasal formulation; Drug: Vehicle (Placebo); Drug: Standard of core (type of therapy is depend of decide of the site) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Measured: 7 days
Secondary outcomes (2)
NIAID ordinal scale
Time to sustained clinical recovery. Sustained clinical recovery will be defined based on self-reported key COVID-19 related symptoms using the NIAID ordinal scale.
- Clinical status on Day 7 and Day 14 assessed on the NIAID 8-point ordinal scale consisting of the following categories:
- Not hospitalized, no limitations on activities;
- Not hospitalized, limitation on activities and/or requiring home oxygen;
- Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care;
- Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise);
- Hospitalized, requiring supplemental oxygen;
- Hospitalized, on noninvasive ventilation or high-flow oxygen devices;
- Hospitalized, on invasive mechanical ventilation or ECMO; and
- Death
Maximum is 1. Not hospitalized, no limitations on activities; Minimum is 8. Death
Measured: 14 days
Peak Plasma Concentration
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)
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2022
- Study startOct 2022 (estimated)
- Primary completionJan 2023 (estimated)
- Study completionJan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- A Phase 1, Randomized, Double-blinded, Vehicle-controlled, Single and Multi-Dose, Dose Escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetics
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Caregen Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05234320
- Sponsor's protocol ID
- CG-S-P01
- Status last verified
- Apr 2022
- First submitted
- 6 Feb 2022
- Last updated
- 22 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double-blinded, Vehicle-controlled, Single and Multi-Dose, Dose Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics in Healthy Volunteers of the Novel Self-Administered Intranasal CG- SpikeDown Antiviral Drug
- ClinicalTrials.gov ID
- NCT05234320
- Acronym / sponsor ID
- CG-S-P01
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Caregen Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- Oct 2022 (estimated)
- Primary completion
- Jan 2023 (estimated)
- Study completion
- Jan 2023 (estimated)
- First posted
- 10 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a phase 1, Randomized, Double-blinded, Vehicle-controlled, Single and Multi-Dose, Dose Escalation Study, which will assess the safety of the Caregen CG-SpikeDown drug self-administered intranasally, for healthy subjects.
The study will include 16 healthy subjects and will be conducted in a clinic under complete supervision of the clinical team. The study will start with evaluation of the lowest dose, that will be increased gradually as long as no safety issues arise.
At the first stage of the study, three (3) subjects will be randomized in a 1:2 ratio to receive vehicle treatment or the active drug, respectively. Each of the 3 subjects will receive a single 25 mg dose of the assigned treatment. These subjects will be referred as Cohort 1. If no safety issues arise, the study will proceed simultaneously to the second and third stages, as depicted in Figure 1 Study Flow Chart.
At the second stage of the study, additional three (3) subjects will be enrolled and randomized in a 1:2 ratio to receive vehicle treatment or the active drug, respectively. Each of the 3 subjects will receive a single 50 mg dose of the assigned treatment. These subjects will be referred as Cohort 2. If no safety issues arise, the study will proceed to the 4th stage.
At the third stage of the study, additional three (5) subjects will be enrolled. The first 2 subjects (out of the 5 subjects) will receive an open label DP treatment-a daily 25 mg dose for 7 days. The open-label subjects will undergo PK assessments as described in the SOA. The next 3 subjects will be randomized in a 1:2 ratio to receive vehicle treatment or the active drug, respectively. Each of the 3 subjects will receive a daily 25 mg dose of the assigned treatment for 7 days. These subjects will be referred as Cohort 3.
At the fourth stage of the study, additional three (5) subjects will be enrolled. The first 2 subjects (out of the 5 subjects) will receive an open label DP treatment-a daily 50 mg dose for 7 days. The open-label subjects will undergo PK assessments as described in the SOA. The next 3 subjects will be randomized in a 1:2 ratio to receive vehicle treatment or the active drug, respectively. Each of the 3 subjects will receive a daily 50 mg dose of the assigned treatment for 7 days. These subjects will be referred as Cohort 4.
The main objective of this study is to assess the toxicity and the pharmacokinetic (PK) parameters of the Drug Product (DP). Subjects will be recruited to the study via study advertisement on social media and the subjects will be adequately compensated. The DP will be self-administered intranasally once daily for 1 day or seven days, depending on the study cohort. PK parameters will be evaluated for 4 subjects participating in the 7 daily DP doses study cohorts. Blood samples for this purpose will be collected at several time points (as described in SOA) during Day 1 and Day 7 of treatment. Toxicity will be evaluated during the entire study period.
Patients receiving a single dose will arrive for a follow-up visit 72 hours following DP administration (24 hours following hospital discharge), again 7 days (+-2 days) following DP administration, and again 14 days (+-2 days) following DP administration. Subjects receiving a daily dose for 7 days will be followed up 14 days (+-2 days) following initial DP administration (7 days (+-2 days) following final DP administration).
Safety review by the DSMB will occur following treatment of the last subject in each study arm.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- Model description
- A Phase 1, Randomized, Double-blinded, Vehicle-controlled, Single and Multi-Dose, Dose Escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetics
| Arm | Type | Receives |
|---|---|---|
| stage I- Healty | Experimental | Drug: CG-SpikeDown, intranasal formulationThe 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 |
| Stage II- Placebo + SOC | Active comparator | Drug: Vehicle (Placebo), Drug: Standard of core (type of therapy is depend of decide of the site)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 |
| Stage II- DP low dose (25 mg) + SOC | Active comparator | Drug: CG-SpikeDown, intranasal formulation, Drug: Vehicle (Placebo), Drug: Standard of core (type of therapy is depend of decide of the site)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 |
| Stage II- DP planned dose (50 mg) + SOC | Active comparator | Drug: CG-SpikeDown, intranasal formulation, Drug: Vehicle (Placebo), Drug: Standard of core (type of therapy is depend of decide of the site)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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CG-SpikeDown, intranasal formulationThe 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 | Stage II- DP low dose (25 mg) + SOC, Stage II- DP planned dose (50 mg) + SOC, stage I- Healty |
| Vehicle (Placebo)patients will receive active drug or placebo in addition to standard of care | Drug | 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)patients will receive active drug or placebo in addition to standard of care | Drug | Stage II- DP low dose (25 mg) + SOC, Stage II- DP planned dose (50 mg) + SOC, Stage II- Placebo + SOC |
Primary outcome
SARS Cov-2 RT-PCR test
Time frame: 7 days
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.
Area under the plasma concentration versus time curve
Time frame: 7 days
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)
2 secondary outcomes
NIAID ordinal scale
Time frame: 14 days
Peak Plasma Concentration
Time frame: 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2022.
- Individual participant dataSharing planned: No
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CG-SpikeDown, intranasal formulation and Standard of core (type of therapy is depend of decide of the site) in people with Healthy, run by Caregen Co. Ltd..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chen Binyamin, B.Sc (050-467-2545, chen.b@technostat.co.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SARS Cov-2 RT-PCR test (time frame: 7 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2022.