Trial Outcomes & Findings for Therapeutic Nanocatalysis to Slow Disease Progression of Amyotrophic Lateral Sclerosis (ALS) (NCT NCT04098406)

Last Updated: 2024-07-03

Results Overview

The Motor Unit Number Index (MUNIX) is a quantitative neurophysiological measure that provides an index of the number of lower motor neurons supplying a muscle. It reflects the loss of motor neurons in patients with ALS. Mean change in the average difference between active treatment and placebo from Baseline through Week 36 for the MUNIXscore(4), which is the sum of the respective MUNIX values for the Abductor Digiti Minimi (ADM), Abductor Pollicis Brevis (APB), Biceps Brachii (BB), and Tibialis Anterior (TA). The average baseline summed values will be indexed to 100%. Changes will be calculated as the percent change from the Baseline index of 100%.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

45 participants

Primary outcome timeframe

36 weeks

Results posted on

2024-07-03

Participant Flow

A Phase 2, Randomised, Double-Blind, Placebo-Controlled Study in Early Symptomatic Amyotrophic Lateral Sclerosis Patients on Stable Background Therapy to Assess Bioenergetic Catalysis with CNM-Au8 to Slow Disease Progression in ALS. Recruitment started on December 19, 2019, with primary completion occurring on July 13, 2021. Participants enrolled at two institutional sites in Australia.

There was no washout or run-in period that occurred between ICF signing and IP initiation. Once the participant signed the ICF and was confirmed to be eligible for the study, they were randomized into the study and dosed with IP.

Participant milestones

Participant milestones
Measure	Placebo The matched placebo used in this study consisted of water, sodium bicarbonate, and food coloring to match volume and color of the experimental treatment Placebo: Placebo is liquid with identical color and taste	30 mg CNM-Au8 30mg suspension of clean-surfaced, faceted, gold nanocrystals in 60ml of sodium bicarbonate buffered water CNM-Au8: CNM-Au8 is a dark red/purple-colored liquid formulation consisting of a stable suspension of faceted clean surfaced elemental gold nanocrystals in buffered deionized water with a nominal concentration of 0.5 mg/mL of gold. The formulation is buffered by sodium bicarbonate present at a concentration of 0.546 mg/mL. There are no other excipients. The drug product is formulated to be taken orally and will be provided in single dose 60 mL HDPE containers.
Overall Study STARTED	22	23
Overall Study COMPLETED	19	22
Overall Study NOT COMPLETED	3	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo The matched placebo used in this study consisted of water, sodium bicarbonate, and food coloring to match volume and color of the experimental treatment Placebo: Placebo is liquid with identical color and taste	30 mg CNM-Au8 30mg suspension of clean-surfaced, faceted, gold nanocrystals in 60ml of sodium bicarbonate buffered water CNM-Au8: CNM-Au8 is a dark red/purple-colored liquid formulation consisting of a stable suspension of faceted clean surfaced elemental gold nanocrystals in buffered deionized water with a nominal concentration of 0.5 mg/mL of gold. The formulation is buffered by sodium bicarbonate present at a concentration of 0.546 mg/mL. There are no other excipients. The drug product is formulated to be taken orally and will be provided in single dose 60 mL HDPE containers.
Overall Study Adverse Event	2	1
Overall Study Withdrawal by Subject	1	0

Baseline Characteristics

Therapeutic Nanocatalysis to Slow Disease Progression of Amyotrophic Lateral Sclerosis (ALS)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=22 Participants The matched placebo to be used in this study will consist of water, sodium bicarbonate, and food coloring to match volume and color of the experimental treatment Placebo: Placebo is liquid with identical color and taste	30 mg CNM-Au8 n=23 Participants 30mg suspension of clean-surfaced, faceted, gold nanocrystals in 60ml of sodium bicarbonate buffered water CNM-Au8: CNM-Au8 is a dark red/purple-colored liquid formulation consisting of a stable suspension of faceted clean surfaced elemental gold nanocrystals in buffered deionized water with a nominal concentration of 0.5 mg/mL of gold. The formulation is buffered by sodium bicarbonate present at a concentration of 0.546 mg/mL. There are no other excipients. The drug product is formulated to be taken orally and will be provided in single dose 60 mL HDPE containers.	Total n=45 Participants Total of all reporting groups
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	61.3 years STANDARD_DEVIATION 10.89 • n=5 Participants	57.0 years STANDARD_DEVIATION 13.32 • n=7 Participants	59.1 years STANDARD_DEVIATION 12.25 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	10 Participants n=7 Participants	19 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants	13 Participants n=7 Participants	26 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	22 Participants n=5 Participants	22 Participants n=7 Participants	44 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	16 Participants n=5 Participants	19 Participants n=7 Participants	35 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Region of Enrollment Australia	22 participants n=5 Participants	23 participants n=7 Participants	45 participants n=5 Participants
Height	167.2 cm STANDARD_DEVIATION 8.16 • n=5 Participants	172.4 cm STANDARD_DEVIATION 11.81 • n=7 Participants	169.9 cm STANDARD_DEVIATION 10.39 • n=5 Participants
Baseline Weight	69.2 kg STANDARD_DEVIATION 14.84 • n=5 Participants	79.1 kg STANDARD_DEVIATION 18.09 • n=7 Participants	74.3 kg STANDARD_DEVIATION 17.14 • n=5 Participants
BMI	24.6 kg/m^2 STANDARD_DEVIATION 3.85 • n=5 Participants	26.5 kg/m^2 STANDARD_DEVIATION 4.86 • n=7 Participants	25.5 kg/m^2 STANDARD_DEVIATION 4.45 • n=5 Participants

PRIMARY outcome

Timeframe: 36 weeks

Population: Intent to Treat

Outcome measures

Outcome measures
Measure	Placebo n=22 Participants The matched placebo used in this study consisted of water, sodium bicarbonate, and food coloring to match volume and color of the experimental treatment Placebo: Placebo is liquid with identical color and taste	30 mg CNM-Au8 n=23 Participants 30mg suspension of clean-surfaced, faceted, gold nanocrystals in 60ml of sodium bicarbonate buffered water CNM-Au8: CNM-Au8 is a dark red/purple-colored liquid formulation consisting of a stable suspension of faceted clean surfaced elemental gold nanocrystals in buffered deionized water with a nominal concentration of 0.5 mg/mL of gold. The formulation is buffered by sodium bicarbonate present at a concentration of 0.546 mg/mL. There are no other excipients. The drug product is formulated to be taken orally and will be provided in single dose 60 mL HDPE containers.
Electromyography Measures of Disease Progression.	-39.6 percent change Standard Error 7.1	-31.8 percent change Standard Error 6.6

SECONDARY outcome

Timeframe: 36 weeks

Population: Intent to Treat

Mean change in FVC - Forced Vital Capacity.

Outcome measures

Outcome measures
Measure	Placebo n=22 Participants The matched placebo used in this study consisted of water, sodium bicarbonate, and food coloring to match volume and color of the experimental treatment Placebo: Placebo is liquid with identical color and taste	30 mg CNM-Au8 n=23 Participants 30mg suspension of clean-surfaced, faceted, gold nanocrystals in 60ml of sodium bicarbonate buffered water CNM-Au8: CNM-Au8 is a dark red/purple-colored liquid formulation consisting of a stable suspension of faceted clean surfaced elemental gold nanocrystals in buffered deionized water with a nominal concentration of 0.5 mg/mL of gold. The formulation is buffered by sodium bicarbonate present at a concentration of 0.546 mg/mL. There are no other excipients. The drug product is formulated to be taken orally and will be provided in single dose 60 mL HDPE containers.
Percentage Mean Change in the Average Difference Between Active Treatment and Placebo From Baseline for Respiratory Function as Measured by Forced Vital Capacity (FVC).	-20.3 percent change Standard Error 5.8	-16.7 percent change Standard Error 5.4

SECONDARY outcome

Timeframe: 36 weeks

Population: Intent to Treat

The Motor Unit Number Index (MUNIX) is a quantitative neurophysiological measure that provides an index of the number of lower motor neurons supplying a muscle. It reflects the loss of motor neurons in patients with ALS. MUNIX will be reviewed via electromyography for the Abductor Pollicus Brevis (APB), Abductor Digiti Minimi (ADM), Biceps Brachii (BB), and Tibialis Anterior (TA). MUNIXscore(4) is the sum of the respective MUNIX values for the above mentioned muscle groups. A higher MUNIX value signifies greater muscle function. A greater decrease in the Mean absolute change signifies worsening muscle function.

Outcome measures

Outcome measures
Measure	Placebo n=22 Participants The matched placebo used in this study consisted of water, sodium bicarbonate, and food coloring to match volume and color of the experimental treatment Placebo: Placebo is liquid with identical color and taste	30 mg CNM-Au8 n=23 Participants 30mg suspension of clean-surfaced, faceted, gold nanocrystals in 60ml of sodium bicarbonate buffered water CNM-Au8: CNM-Au8 is a dark red/purple-colored liquid formulation consisting of a stable suspension of faceted clean surfaced elemental gold nanocrystals in buffered deionized water with a nominal concentration of 0.5 mg/mL of gold. The formulation is buffered by sodium bicarbonate present at a concentration of 0.546 mg/mL. There are no other excipients. The drug product is formulated to be taken orally and will be provided in single dose 60 mL HDPE containers.
Mean Absolute Change of the Average Difference Between Active Treatment and Placebo From Baseline Through Week 36 for the MUNIXscore(4).	-141.3 index score Standard Error 27	-123.6 index score Standard Error 25

OTHER_PRE_SPECIFIED outcome

Timeframe: 36 weeks

The baseline average will be indexed to 100%, and changes at Week 12 and Week 36 will be calculated as the percent change from the Baseline index of 100%.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 36 weeks

MUNIXscore(4) is the mean of the respective MUSIX values for the ADM, APB, BB, and TA. The average baseline mean values will be indexed to 100%. Changes will be calculated as the percent change from the Baseline index of 100%.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 36 weeks

NPI is a method to quantify peripheral disease burden in ALS. NPI is defined as the ulnar nerve (ADM \[CMAP peak amplitude\] / ADM \[distal motor latency\]) x (ADM \[f-wave %\]).

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 36 weeks

The SI is an early clinical feature that is used as a neurophysiological biomarker for evaluating ALS. Split Hand Index, defined as the first dorsal interosseous (FDI)Peak CMAP Amplitude \* APBPeak CMAP Amplitude/ADMPeak CMAP Amplitude.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 36 weeks

The ALS Functional Rating Scale-Revised (ALSFRS-R) is a validated rating instrument for monitoring the progression of disability in patients with ALS. Maximum score is 40, minimum is 0. A higher score signifies greater function.

Outcome measures

Outcome measures
Measure	Placebo n=22 Participants The matched placebo used in this study consisted of water, sodium bicarbonate, and food coloring to match volume and color of the experimental treatment Placebo: Placebo is liquid with identical color and taste	30 mg CNM-Au8 n=23 Participants 30mg suspension of clean-surfaced, faceted, gold nanocrystals in 60ml of sodium bicarbonate buffered water CNM-Au8: CNM-Au8 is a dark red/purple-colored liquid formulation consisting of a stable suspension of faceted clean surfaced elemental gold nanocrystals in buffered deionized water with a nominal concentration of 0.5 mg/mL of gold. The formulation is buffered by sodium bicarbonate present at a concentration of 0.546 mg/mL. There are no other excipients. The drug product is formulated to be taken orally and will be provided in single dose 60 mL HDPE containers.
Mean Change in Average ALSFRS-R Score	-5.8 score on a scale Standard Error 0.9	-4.8 score on a scale Standard Error 0.8

OTHER_PRE_SPECIFIED outcome

Timeframe: 36 weeks

Revised Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS-R)

Outcome measures

Outcome measures
Measure	Placebo n=22 Participants The matched placebo used in this study consisted of water, sodium bicarbonate, and food coloring to match volume and color of the experimental treatment Placebo: Placebo is liquid with identical color and taste	30 mg CNM-Au8 n=23 Participants 30mg suspension of clean-surfaced, faceted, gold nanocrystals in 60ml of sodium bicarbonate buffered water CNM-Au8: CNM-Au8 is a dark red/purple-colored liquid formulation consisting of a stable suspension of faceted clean surfaced elemental gold nanocrystals in buffered deionized water with a nominal concentration of 0.5 mg/mL of gold. The formulation is buffered by sodium bicarbonate present at a concentration of 0.546 mg/mL. There are no other excipients. The drug product is formulated to be taken orally and will be provided in single dose 60 mL HDPE containers.
Mean Change Between Active Treatment and Placebo in the Proportion of Patients Experiencing a > 6-point Decline in the ALSFRS-R Between Active Treatment and Placebo. Declined: No	4 Participants	11 Participants
Mean Change Between Active Treatment and Placebo in the Proportion of Patients Experiencing a > 6-point Decline in the ALSFRS-R Between Active Treatment and Placebo. Declined: Yes	18 Participants	12 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 36 weeks

The ALS Functional Rating Scale-Revised (ALSFRS-R) is a validated rating instrument for monitoring the progression of disability in patients with ALS.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 36 weeks

Population: Intent to Treat

the Combined Assessment of Function and Survival (CAFS). CAFS ranks patients' clinical outcomes based on survival time and change in the ALS Functional Rating Scale-Revised (ALSFRS-R) score. Each patient's outcome is compared to every other patient's outcome, assigned a score, and the summed scores are ranked. The mean rank score for each treatment group can then be calculated. A higher mean CAFS score indicates a better group outcome. There is no maximum or minimum due to ranking.

Outcome measures

Outcome measures
Measure	Placebo n=22 Participants The matched placebo used in this study consisted of water, sodium bicarbonate, and food coloring to match volume and color of the experimental treatment Placebo: Placebo is liquid with identical color and taste	30 mg CNM-Au8 n=23 Participants 30mg suspension of clean-surfaced, faceted, gold nanocrystals in 60ml of sodium bicarbonate buffered water CNM-Au8: CNM-Au8 is a dark red/purple-colored liquid formulation consisting of a stable suspension of faceted clean surfaced elemental gold nanocrystals in buffered deionized water with a nominal concentration of 0.5 mg/mL of gold. The formulation is buffered by sodium bicarbonate present at a concentration of 0.546 mg/mL. There are no other excipients. The drug product is formulated to be taken orally and will be provided in single dose 60 mL HDPE containers.
Mean Change Between Active Treatment and Placebo for the Combined Assessment of Function and Survival (CAFS), a Joint-rank Analysis of Function (ALSFRS-R) and Overall Survival	-4.6 Average change of rank Standard Error 5.2	4.4 Average change of rank Standard Error 5.1

OTHER_PRE_SPECIFIED outcome

Timeframe: 36 weeks

ALS Clinical Worsening is defined as the occurrence of death, tracheostomy, use of non-invasive ventilatory respiratory support, insertion of a gastrostomy tube, or a 6-point drop in the ALSFRS-R score. This outcome measures the number of participants that experienced ALS clinical worsening event within the 36 week time frame.

Outcome measures

Outcome measures
Measure	Placebo n=22 Participants The matched placebo used in this study consisted of water, sodium bicarbonate, and food coloring to match volume and color of the experimental treatment Placebo: Placebo is liquid with identical color and taste	30 mg CNM-Au8 n=23 Participants 30mg suspension of clean-surfaced, faceted, gold nanocrystals in 60ml of sodium bicarbonate buffered water CNM-Au8: CNM-Au8 is a dark red/purple-colored liquid formulation consisting of a stable suspension of faceted clean surfaced elemental gold nanocrystals in buffered deionized water with a nominal concentration of 0.5 mg/mL of gold. The formulation is buffered by sodium bicarbonate present at a concentration of 0.546 mg/mL. There are no other excipients. The drug product is formulated to be taken orally and will be provided in single dose 60 mL HDPE containers.
Time to ALS Clinical Worsening	13 participants	5 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 36 weeks

Change in FS score = (Max ALSFRS-R minus current ALSFRS-R score) divided by symptom duration in months.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 36 weeks

ALS Specific Quality of Life - Short Form (ALSSQOL-SF) Questionnaire will be completed at multiple times during the trial and the scores will be averaged. Maximum score is 10, minimum score is 0. A higher score signifies a higher quality of life.

Outcome measures

Outcome measures
Measure	Placebo n=22 Participants The matched placebo used in this study consisted of water, sodium bicarbonate, and food coloring to match volume and color of the experimental treatment Placebo: Placebo is liquid with identical color and taste	30 mg CNM-Au8 n=23 Participants 30mg suspension of clean-surfaced, faceted, gold nanocrystals in 60ml of sodium bicarbonate buffered water CNM-Au8: CNM-Au8 is a dark red/purple-colored liquid formulation consisting of a stable suspension of faceted clean surfaced elemental gold nanocrystals in buffered deionized water with a nominal concentration of 0.5 mg/mL of gold. The formulation is buffered by sodium bicarbonate present at a concentration of 0.546 mg/mL. There are no other excipients. The drug product is formulated to be taken orally and will be provided in single dose 60 mL HDPE containers.
Mean Change in Average Difference Between Active Treatment and Placebo for the ALSSQOL-Short Form Questionnaire (ALSSQOL-SF)	-1.2 Average score on a scale Standard Error 0.3	-0.3 Average score on a scale Standard Error 0.2

OTHER_PRE_SPECIFIED outcome

Timeframe: 36 weeks

The CGI scales (assessing both severity \[CGI-S\] and improvement \[CGI-I\]) provides a brief assessment of the clinician's view of the patient's global functioning and severity of current disease state and can be utilized to assess for changes in disease progression over the course of a clinical trial.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 36 weeks

The PGI scales (assessing both severity \[PGI-S\] and improvement \[PGI-I\]) provides a brief assessment of the patient's view global functioning and severity of current disease state and can be utilized to assess for changes in disease progression over the course of a clinical trial.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 36 weeks

Outcome measures

Outcome data not reported

Adverse Events

Placebo

Serious events: 5 serious events

Other events: 17 other events

Deaths: 2 deaths

30 mg CNM-Au8

Serious events: 5 serious events

Other events: 17 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Placebo n=22 participants at risk The matched placebo used in this study consisted of water, sodium bicarbonate, and food coloring to match volume and color of the experimental treatment Placebo: Placebo is liquid with identical color and taste	30 mg CNM-Au8 n=23 participants at risk 30mg suspension of clean-surfaced, faceted, gold nanocrystals in 60ml of sodium bicarbonate buffered water CNM-Au8: CNM-Au8 is a dark red/purple-colored liquid formulation consisting of a stable suspension of faceted clean surfaced elemental gold nanocrystals in buffered deionized water with a nominal concentration of 0.5 mg/mL of gold. The formulation is buffered by sodium bicarbonate present at a concentration of 0.546 mg/mL. There are no other excipients. The drug product is formulated to be taken orally and will be provided in single dose 60 mL HDPE containers.
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	0.00% 0/22 • Adverse events were collected from the time of the signing of the Informed Consent to 28 days after the last day of study drug administration, up to 46 weeks.	13.0% 3/23 • Adverse events were collected from the time of the signing of the Informed Consent to 28 days after the last day of study drug administration, up to 46 weeks.
Respiratory, thoracic and mediastinal disorders Acute Respiratory Failure	0.00% 0/22 • Adverse events were collected from the time of the signing of the Informed Consent to 28 days after the last day of study drug administration, up to 46 weeks.	4.3% 1/23 • Adverse events were collected from the time of the signing of the Informed Consent to 28 days after the last day of study drug administration, up to 46 weeks.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	4.5% 1/22 • Adverse events were collected from the time of the signing of the Informed Consent to 28 days after the last day of study drug administration, up to 46 weeks.	0.00% 0/23 • Adverse events were collected from the time of the signing of the Informed Consent to 28 days after the last day of study drug administration, up to 46 weeks.
Respiratory, thoracic and mediastinal disorders Respiratory Failure	0.00% 0/22 • Adverse events were collected from the time of the signing of the Informed Consent to 28 days after the last day of study drug administration, up to 46 weeks.	4.3% 1/23 • Adverse events were collected from the time of the signing of the Informed Consent to 28 days after the last day of study drug administration, up to 46 weeks.
Respiratory, thoracic and mediastinal disorders Haemorrhoids	0.00% 0/22 • Adverse events were collected from the time of the signing of the Informed Consent to 28 days after the last day of study drug administration, up to 46 weeks.	4.3% 1/23 • Adverse events were collected from the time of the signing of the Informed Consent to 28 days after the last day of study drug administration, up to 46 weeks.
Gastrointestinal disorders Large intestine polyp	0.00% 0/22 • Adverse events were collected from the time of the signing of the Informed Consent to 28 days after the last day of study drug administration, up to 46 weeks.	4.3% 1/23 • Adverse events were collected from the time of the signing of the Informed Consent to 28 days after the last day of study drug administration, up to 46 weeks.
Injury, poisoning and procedural complications Fall	4.5% 1/22 • Adverse events were collected from the time of the signing of the Informed Consent to 28 days after the last day of study drug administration, up to 46 weeks.	0.00% 0/23 • Adverse events were collected from the time of the signing of the Informed Consent to 28 days after the last day of study drug administration, up to 46 weeks.
Injury, poisoning and procedural complications Femoral Neck Fracture	4.5% 1/22 • Adverse events were collected from the time of the signing of the Informed Consent to 28 days after the last day of study drug administration, up to 46 weeks.	0.00% 0/23 • Adverse events were collected from the time of the signing of the Informed Consent to 28 days after the last day of study drug administration, up to 46 weeks.
Nervous system disorders Amyotrophic lateral sclerosis	4.5% 1/22 • Adverse events were collected from the time of the signing of the Informed Consent to 28 days after the last day of study drug administration, up to 46 weeks.	0.00% 0/23 • Adverse events were collected from the time of the signing of the Informed Consent to 28 days after the last day of study drug administration, up to 46 weeks.
Nervous system disorders Motor neurone disease	4.5% 1/22 • Adverse events were collected from the time of the signing of the Informed Consent to 28 days after the last day of study drug administration, up to 46 weeks.	0.00% 0/23 • Adverse events were collected from the time of the signing of the Informed Consent to 28 days after the last day of study drug administration, up to 46 weeks.

Other adverse events

Additional Information

Jeremy Evan, PA-C

Clene Nanomedicine

Phone: 5419086335

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60